Careers



+ Application Developer Oracle III

Duration & Type: 12+ months Contract with a major pharmaceutical client

Location: Cambridge, Massachusetts

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Description:

An experienced Oracle Application Developer needed to work on a project to clean, map, transform, and load (ETL and CDISC domain mapping) clinical data sets into an Oracle 12C-based data warehouse.

Required:

  • BA/BS degree and related industry experience
  • 6+ years of experience in developing/maintaining integration solutions within the life sciences – pharma/biotech/CRO
  • Full life-cycle experience – including requirement gathering, data analysis, design, development, testing and systems implementation
  • Strong NodeJS and JavaScript for clinical programming skills required. Python/R experience a plus
  • In-depth knowledge of Oracle development including PL/SQL, SQL Loader and ETL tools required
  • Strong SQL Programming (Oracle) experience required – Oracle 12 preferred, with knowledge on JSON querying into a relational format
  • Expertise in building RESTful web services using XML/JSON payloads, interacting with external web services, databases, and data warehouses, is required
  • Strong experience in data mapping using CDISC 3.2 standards required.
  • Experience in mapping safety and oncology data domains (identification, results, drug exposure, tumor response), especially biomarker and NGS data, from early clinical trials strongly preferred
  • Strong experience extracting, transforming, and loading (ETL) preclinical and clinical data from a variety of data sources to a target Oracle data warehouse required
  • Experience with clinical CDISC SEND & SDTM standards (domain definition and controlled terminology) required
  • Knowledge of various design patterns including third-normal, denormalized, star schema and snowflake
  • Knowledge of Data warehousing design topologies including ODS, information factory, independent marts, and CDI
  • Knowledge of SOA design principles and best practices required
  • Experience in tools and platforms include Toad, Erwin, DataStage, MetaStage, QualityStage, Trillium, Informatica, Syncsort, Control-M, Linux/Unix and Microsoft Operating Systems
  • Familiarity with the use of AWS platform components helpful
  • Understanding of Authentication & Authorization protocols
  • Excellent communication and presentation skills, both verbal & written, required
  • Ability to work successfully in a fast-paced team environment. Must be responsible for proper completion of assigned tasks and duties
  • Able to interact on an occasional basis with clinical customer groups to resolve queries as needed

For consideration, please send resume to career@infoquestgroup.com


+ RSA Archer Developer

Duration & Type: 12 months Contract

Location: Central New Jersey

No. of Positions: 2

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Responsibilities:

  • Design and implement GRC solutions in RSA Archer Platform
  • Develop RSA Archer eGRC data integration feeds to/from other systems as required
  • Configure and support Archer GRC Platform
  • Maintain Archer GRC platform components – Server hardware, SQL databases, Windows services, RSA Archer product software
  • Conduct requirements gathering sessions with new RSA Archer eGRC user groups and facilitate RSA Archer end users training
  • Document business processes or technical procedures

Required:

  • A minimum of 5 years of professional experience as a software developer/programmer analyst with background in VB/MS SQLServer and/or Java/Oracle
  • Hands on knowledge of RSA Archer eGRC configuration involving various Archer modules
  • Basic knowledge of information security and GRC topics such as policy management, risk management, compliance management and business continuity management
  • Skill in assessing vulnerabilities and instituting technology controls in an enterprise environment
  • Must be able to work independently in a highly dynamic environment and the ability to collaborate with a cross-functional team

For consideration, please send resume to career@infoquestgroup.com


+ Linux Administrator

Duration & Type: 12 months Contract

Location: Central New Jersey

No. of Positions: Multiple

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Required:

  • Expert level Linux administration skills with experience in
    • Installation, configuration, management, patch management
    • File systems, disk mirroring, monitoring disk space
    • Configuring and troubleshooting network and DNS
    • Security, user support, logging
    • Virtualization
    • Shell scripting
    • Setup, configuring and using SSH
  • Additional preferred skills: Chef, Docker, Nova, Nagios, Perl scripting, Java, MariaDB, Git, VCenter
  • Must have at least 4 years of experience and hands on experience working in large scale environments
  • Must be able to work independently on concurrent tasks in a highly visible position
  • Must have excellent communications skills along with the ability to collaborate within a cross functional team in a highly dynamic environment

For consideration, please send resume to career@infoquestgroup.com


+ Data Scientist

Duration & Type: 12 months Contract

Location: Plano, Texas

No. of Positions: Multiple

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Description: This position is for a Data Scientist who can think strategically and intuitively about uses of data and interaction of data usage with data design; and has the curiosity and skepticism while analyzing data.

Responsibilities:

  • Work closely with the IT, Sales and Marketing organizations functional leads to formulate and deliver insights to production
  • Perform data studies and data discovery around new data sources or new uses for existing data sources
  • Design and build large and complex data sets from spurious sources
  • Design and implement statistical data quality procedures around data sources
  • Use statistical packages to perform statistical analyses with data sets
  • Implement software solution required for accessing, handling and updating data appropriately
  • Visualize and report data findings to provide insights for the organization
  • Serve as a functional lead and mentor to other team members within the organization
  • Provide domain expertise to external vendors, partners, and members of other organizations

Required:

  • Experience creating models utilizing Machine Learning and/or Statistics
  • Exposure to the Hadoop Ecosystem tools (e.g Spark, MapReduce/Tez) or other big data technologies
  • Experience manipulating big and noisy datasets (e.q. SQL, Pig, Hive)
  • Bachelors or Masters (preferred) degree in Computer Science, Math or Scientific Computing; Data Analytics, Machine Learning or equivalent experience.
  • Minumum 2 to 8 years of experience
  • Nice to have – Knowledge of scalable data visualization techniques
  • Ability to create prototypes quickly

For consideration, please send resume to career@infoquestgroup.com



+ Application Developer - BIG DATA

Duration & Type: 12 months Contract

Location: Plano, Texas

No. of Positions: Multiple

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Responsibilities:

  • Interact with users to define system requirements and/or necessary modifications
  • Be responsible for all functions involved in the development and/or maintenance of new or existing applications – softwarde development, testing and documentation

Required:

  • Application Design and Development experience in Linux environment using C/C++ and Python
  • Solid experience with Big Data tools – Hadoop, NoSQL, Kafka
  • Experience/Competency in – Virtual environments, AIC, OpenStack
  • 8- 10 years of total professional experience
  • Bachelors or Masters degree in Computer Engineering, Computer Science, Applied Science, Electrical Engineering, or Math; or equivalent experience.

For consideration, please send resume to career@infoquestgroup.com


+ System engineer – BIG DATA

Duration & Type: 12 months Contract

Location: Plano, Texas

No. of Positions: Multiple

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Responsibilities:

  • Responsible for translating the core business requirements into the final technical solution definition (consisting of platform, network, software, etc.)
  • Analyze, document and define technology systems for maximizing reuse of target platforms such as API, data fabric, or data routers platforms
  • Coordinate delivery of design, specification, and integration of subsystems for the solution
  • Assess (proof of concept) and recommend solutions (algorithms and products) to improve the current systems
  • Help engineer and deliver integrated hardware and software solutions or service that meet performance, usability, scalability, reliability, and security needs

Required:

  • Strong knowledge of the Hadoop ecosystem, Spark, Python, Java and other Big Data technologies
  • Prefer in-depth knowledge of UML design
  • Expert level technical professional with experience in Business Case Development
  • Capacity to translate complex and open-ended business challenges into concise data-driven problems
  • Requires 3-10 years of professional experience depending upon the hiring level
  • Ability to communicate with a wide range of audiences – from executives needing big picture to peers
  • Bachelors/Masters/PhD degree in Computer Engineering, Computer Science, Applied Science, Electrical Engineering, or Math or equivalent experience
  • Experience/Competency in one or more of the following –
    • Application Design, Architecture, Application Programming Interface (API)
    • Service Oriented Architecture (SOA), System and Technology Integration
    • Emerging Technologies, Trends and Directions
    • Network Architecture, Technology Architecture
    • Product and Service Design and Development
    • Agile Methodology (SCRUM)
  • A self-starter and a team player who is passionate about constantly learning new skills in a fast-paced environment

For consideration, please send resume to career@infoquestgroup.com


+ VMware Engineer

Duration & Type: 12 months Contract

Location: Reston, Virginia

No. of Positions: 2

Required:

  • Must have at least 4 years of experience and hands-on experience working with large scale VMware environments.
  • System administration experience in a VMware with substantial knowledge of the vSphere 5.x, 5.5 and 6.0, SRM 6.1, vROPS.
  • Strong working knowledge of SRM, vSphere, VMware Convertor. Experience using PlateSpin is a plus.
  • Experience with VM migration both at storage and VM level required.
  • Experience with CISCO UCS, Storage technologies is preferable.
  • Must have strong scripting skills has ESXcli, PowerShell,
  • Must be able to work independently on multiple concurrent tasks in a highly dynamic environment with strong customer service skills, teaming skills and the ability to collaborate within a cross-functional team.

For consideration, please send resume to career@infoquestgroup.com


+ Scrum Master

Duration & Type: 12 months Contract

Location: Reston, Virginia

No. of Positions: 1

Description: This position is for a Scrum Master role for the System Team (not part of Agile development team)

Required:

  • Highly experienced (8-10 years) Scrum Master who has a solid grasp and actual experience with Agile practices.
  • Experienced in working with Scrum Teams, knowledge of Kanban and if possible, SAFe. (SAFe knowledge or experience though is a nice-to-have skill.)
  • Shpould have strong communication and presentation skills and also have working knowledge of JIRA and CONFLUENCE tools

For consideration, please send resume to career@infoquestgroup.com


+ Sr. Java Developer

Duration & Type: 12 months Contract

Location: Reston, Virginia

No. of Positions: Multiple

Required:

  • 6+ years of experience as a developer or software engineer
  • Expert in Java, Javascript, or Python programming languages
  • Experiences in SQL development such as stored procedures and packages
  • Must have good experience in Java Programming, Spring MVC/Spring, REST web services, API
  • Should carry at least 1-2 years of experience on developing application using Java and AWS (Amazon Web Services) cloud technologies
  • Hands on software development using AWS Postgres RDS, Redshift, Glue, JSON
  • Strong shell scripting skill such as Korn shell
  • Experience in working in Operations environment in a large enterprise
  • Experience in DevOps tools, agile principles, SDLC and automation
  • Analytical/Problem-solving ability – ability to quickly evaluate an issue, resolve it or implement a workaround with consistent accuracy and success
  • Should be able to take ownership and act with high Sense of Urgency – this job requires the individual to work like an entrepreneur, self-motivated and self-starter

Good to have:

  • AWS development experience using Lambda, EMR, Hive, or other similar big data framework.
  • AWS certified developer – associate or professional

For consideration, please send resume to career@infoquestgroup.com


+ Portfolio Analysis and Reporting Manager

Duration & Type: 12 months Contract with with our client – a global leader in the pharmaceutical industry

Location: East Hanover, New Jersey

Description:

Lead (accountable/responsible) the design, implementation, and operation of Enterprise IT Project Portfolio Management, Data Science, Reporting and Analysis capabilities, enabling a world-class IT Project Portfolio investment decision-making environment for NBS IT, driving value creation focus as well as overall sound governance discipline for the organization.

Responsibilities:

  • Design, implement and operate the enterprise IT project and portfolio management data science, reporting and analysis capabilities for measurement, tracking and management of overall IT portfolio performance
  • Structure, govern and evolve IT project portfolio data model to ensure organization capability to define actionable insights and clear portfolio narratives/scenarios in alignment with overall IT data integration, business intelligence (BI) and enterprise information management programs.
  • Determine overall portfolio data management modeling guidelines, best practices and approved standardized modeling techniques Oversee key practices working with IT function / COEs to ensure that project and portfolio data standards, policies, and guidelines are followed.
  • Manage or help drive steering of core project portfolio management data and reporting platforms.
  • Take accountability to ensure adherence with Security and Compliance policies and procedures within IT Project Portfolio service scope.

Required:

  • Education: MBA working and thinking level or comparable education / experience.
  • 10 years of business / IT experience.
  • Demonstrated senior leadership skills: 5 years’ experience in senior IT management positions in a matrix organization.
  • Extensive expertise in several IT disciplines and broad knowledge of all disciplines of IT.

For consideration, please send resume to career@infoquestgroup.com


+ Project Portfolio Service Delivery Manager

Duration & Type: 6 months Contract with with our client – a global leader in the pharmaceutical industry

Location: East Hanover, New Jersey

Description:

The IT Portfolio Service Delivery Manager is responsible for implementing practices within the IT Project & Portfolio management community and monitoring Project Portfolio reports which go upstream to the senior IT Leadership, and via the Demand & Supply Managers, PMs and Service Delivery Leads across all IT Units. This position has a Global, cross-divisional, cross-functional scope responsible for managing and maintaining Project and Portfolio Practices including ITIC, Budget, Demand, Forecast etc. This includes establishing and monitoring metrics of practices, all operational activities to support practice

Responsibilities:

  • Execute the portfolio investment reviews (ITIC) and drive roadmap of the process. Includes creation of bi-weekly portfolio reports to the CIO and his directs on portfolio trends and spend.
  • Responsible for all aspects of the portfolio investment reviews, including all preparation and follow-up work.
  • Use metrics and tools to create the story of the overall delivery health of the tech organization.
  • Support senior leadership and business partners in documenting the yearly tech roadmap.
  • Assure Portfolio aligns with finance and strat/budget processes.
  • Manage the Annual Project Portfolio Process
    • Communicate Process and Portfolio changes to IT Functions
    • Assess Portfolio Changes
    • Manage Process in close liaison with Finance
  • Design requirement and working with IT Functions to ensure practices are well communicated and understood.
  • Facilitate PMO stakeholders and leadership toward consensus around the mission and vision of the PMO organization
  • Lead the identification and implementation of the project management processes, methods, tools, guidelines, and standards in order to support all project teams and stakeholders to ensure high probability of successful project delivery
  • Lead and manage the PMO partnership with an IT Functions to deliver their portfolio
  • Responsible for collecting and implementation of feedback from the functions for the practice monitoring, measurement, and steering of the execution activities across IT (i.e. metrics definition, monitoring and analysis of practices execution.

Required:

  • Degree in Information, Computer Science or Life Sciences desired
  • Proven portfolio management knowledge and project management experience (7 years min)
  • Proven experience in project budgeting with experience in project financial processes and systems
  • Strong analytical skills and high degree of detailed oriented working style
  • Excellent interpersonal (verbal and written) communication skills to support working in project environments that include internal, external and customer teams
  • Fluent in English – oral and written
  • Extremly strong process creation and ownership experience
  • Ability to manage multiple priorities and assess and adjust quickly to changing priorities
  • Experienced IT Portfolio leader with global experience who has managed global teams and can work with senior IT Leadership
  • Comfortable working in a global, multi-cultural and matrix environment with teams not co-located.
  • Experience with Clarity or similar PPM tools, Excel, macros; strong presentation skills
  • Self-starter, hands-on, strong team player, flexible.

For consideration, please send resume to career@infoquestgroup.com


+ Project Support Engineer - Validation

Duration & Type: 12 months Contract with with our client – a global leader in the pharmaceutical industry

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Location: Morris Plains, New Jersey

Responsibilities:

  • Assist in SOP development for Data backup, disaster recovery, data recovery for GXP Computerized Systems that include but not limited to Lab systems (such as Spectrophotometers, FlowCytometers, cell counters, Microbial Detection Units, etc.), and Building Automation Systems (Continuum, Siemens, etc).
  • Assist in gap assessment of various systems (as above) to ensure compliance and global alignment.
  • Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
  • Work closely with multiple disciplines, including QC labs, manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to support a diverse portfolio of projects.
  • Ensure compliance with Company’s Information Security Risk Management policies.
  • Ensure know-how transfer during projects between external consultants to internal staff.

Required:

  • Skilled in risk assessment methodologies, and project organization.
  • Knowledge of IT infrastructure/networks related to automation systems.
  • Ability to negotiate favorable outcomes while maintaining positive working relationship.
  • Familiar with compliance requirements, Health Authority guidances, and industry standards (e.g. FDA, EMA GMP, GLP, GCP, GQO, Records Management, BCM/Disaster Recovery, and GAMP).
  • 5+ years experience with automation systems.
  • Extended interdisciplinary technical knowledge Experienced in a GMP regulated environment (pharmaceutical preferable).
  • Science Degree or equivalent in Information Technology and/or relevant Engineering or related field Education.
  • Familiarity with industry standards 21 CFR Part 11, Validation, and GAMP.
  • Excellent written and verbal communication skills; interpersonal and collaborative skills.
  • Ability to communicate quality, compliance, security and risk-related concepts to technical and nontechnical audiences.
  • Strong organizational and project management skills, scheduling and time management.

For consideration, please send resume to career@infoquestgroup.com


+ IT Project Manager

Duration & Type: 6+ months Contract

Location: White Plains, New York

Description:

An experienced IT Project Manager is needed for a long term project. Projects are related to SAP enhancements, therefore will strongly prefer a candidate with project management experience involving SAP projects.

Responsibilities:

  • Coordinating internal resources and vendors for the flawless execution of projects
  • Ensuring that all projects are delivered on-time, within scope and within budget
  • Project management responsibilities include delivering every project on time within budget and scope. Project managers should have a background in business skills, management, budgeting, and analysis.
  • Project managers are skilled at getting the best out of the people and projects that they oversee. They thrive when planning projects and working with project teams.
  • Coordinate internal resources and third parties/vendors for the flawless execution of projects
  • Ensure that all projects are delivered on-time, within scope and within budget
  • Developing project scopes and objectives, involving all relevant stakeholders and ensuring technical feasibility
  • Ensure resource availability and allocation
  • Develop a detailed project plan to track progress
  • Use appropriate verification techniques to manage changes in project scope, schedule, and costs
  • Measure project performance using appropriate systems, tools, and techniques
  • Report and escalate to management as needed
  • Manage the relationship with the client and all stakeholders
  • Perform risk management to minimize project risks
  • Establish and maintain relationships with third parties/vendors
  • Create and maintain comprehensive project documentation

Required:

  • PMP Certification is a must
  • Proven recent work experience as an IT project manager, especially managing projects related to SAP
  • Applicant does not have to be hands-on with SAP, but understanding of SAP application landscape is required
  • Should have experience working with PMO
  • Great educational background, preferably in the fields of computer science or engineering

For consideration, please send resume to career@infoquestgroup.com



+ SAP SD Consultant (Functional)

Duration & Type: 6+ months renewable Contract

Location: Stamford, Connecticut

Description:

Looking for a SAP Functional SD Consultant with a strong experience in integration with ISU Billing. The consultant will be work together with SAP portfolio team members under the direction of SAP Manager.

Responsibilities:

  • Play a key role in integration of SD with ISU-Billing module from initial set-up to the final delivery of the result
  • Review implementation of net metering, including – Concept, Configuration, Remote Net metering (Cross Contract Billing), Meter Configuration
  • Work with the other teams to analyze requirements, prepare requirement documentation.
  • Based on user requirements analysis: Propose, configure, document and test business solution in SAP SD and IS-U application according to the functional and technical requirement
  • Prepare and maintain end user procedures for all SAP related functionality

Required:

  • Functional expert in SAP Sales & Distribution (SD) module
  • Strong knowledge of SD and IS-U Billing Processes
  • Strong in implementation, configuration, customization and maintenance(support) of SAP SD and IS-U module
  • Knowledge of Net metering Concepts
  • Minimum of 8+ years of experience in directly related SAP functions.
  • Ability to work in a team environment with both employees and consultants is a must
  • Must be prepared to participate in fast track knowledge transfer of complex environment from a number of highly experienced consultants
  • Must have the ability to communicate effectively across many different levels of technical and business acumen.
  • Strong time management skills and multi-tasking capabilities
  • Strong analytical skills focused on creating optimal solutions
  • Good understanding of technical concepts, principles and terminology
  • Bachelor’s Degree

For consideration, please send resume to career@infoquestgroup.com



+ Network Monitoring Engineer

Duration & Type: 3 months contract, with a strong possibility for an extension up to a year.

Location: Remote Position, can work remotely

Description: The position requires a senior system/network engineer with experience on ZENOSS monitoring platform related to its administration/integration, not simply as a user.

Required:

  • 8+ years of IT experience in System and Network administration
  • 4+ years of hands-on experience in ZENOSS enterprise monitoring solution
  • Hands on experience in customizing Zenoss transformation rules for network and server monitoring
  • Deep understanding of Zenoss internals – i.e. database schema, log files, Zenoss product architecture (API, Zenpacks, remote collectors, etc.)
  • Experience in managing minimum 1000+ servers and 300+ network devices through Zenoss.
  • Strong understanding of Network protocols – ICMP, TCP-IP and SNMP
  • Hands on experience in Unix and Windows environment
  • Strong knowledge and hands-on experience in writing Shell and Perl script

For consideration, please send resume to career@infoquestgroup.com


+ Systems Administrator

Duration & Type: 12 months Contract with a major pharmaceutical client

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Location: Sinking Spring, Pennsylvania

Roles & Responsibilities:

  • Support Windows servers and workstations at GxP manufacturing facility.
  • Perform day-to-day technical support and troubleshooting for Windows based systems and applications.
  • Perform system administration tasks for security, backup & restoration, databases, Ethernet and wireless networking.
  • Work with onsite IT team for day-to-day support. Coordinate support with onsite and remote support teams and escalate issues as appropriate.
  • Provide limited “on-call” support during off hours (approximately on-call for 1 week every month).
  • Candidate will also work on several projects to upgrade applications off of Windows XP to a new Windows 7 or 10 computer.
  • Candidate should be familiar with testing application migrations and executing documented testing to verify migration per GxP standards (such as installation qualification protocols).

Required:

  • 6-8 years technical experience in Windows based systems management and support.
  • Familiarity with GxP manufacturing environment & GxP validation processes preferred
  • Experience in Microsoft Windows Server and Workstation administration (XP, 7, 2003, 2008, 2012)
  • Experience in supporting Windows based applications.
  • Basic familiarity with simple SQL Server database administration
  • Experience in Network connectivity/services – TCP/IP, Ethernet, wireless
  • Experience working with escalating and coordinating with offsite corporate and third party support teams
  • Education: Bachelor’s Degree preferred, but not required.

For consideration, please send resume to career@infoquestgroup.com


+ Network Engineer with Splunk Experience

Description:

Seeking experienced Network Engineers/Developers who would have the desire to grow their careers in operational intelligence field with Splunk skills.

Minimum Requirement:

  • A degree in Computer Science or Information Systems or an Engineering discipline
  • Understanding of networking essentials
  • Basic XML skills & basic/intermediate knowledge of statistics
  • Exposure to System/Network/Firewall admin tasks
  • Analytical and rational mindset for troubleshooting and interpretation
  • Ability to multitask and solve complex technical problems

Preferred:

  • 3+ years experience in IT infrastructure, networking, architecture, administration, or security
  • Experience in scripting language (PERL/shell etc)
  • Any level of experience with Splunk in a large enterprise environment
  • Splunk training and/or certifications would be a major advantage

For consideration, please send resume to career@infoquestgroup.com



+ Salesforce Developer

Duration & Type: 12+ months Contract with a major financial services firm

Location: Charlotte, North Carolina

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Responsibilities:

  • Analyze and identify gaps in functional/business requirements and effectively communicate the same with both Business and Functional analysts
  • Assess the impacts on technical design because of the changes in functional requirements
  • Understand functional requirements and develop technical design and code using standard patterns and effectively communicate the same to the team members
  • Perform independent code reviews and execute unit tests on modules developed by self and other junior team members on the project

Required Qualifications:

  • Should have minimum 5 years of experience in Salesforce.com
  • Good experience in Salesforce.com Development environment(S-Controls, AJAX Toolkit, Apex API)
  • Should be strong in Apex, Visual force
  • Should have experience in integration and Configuration
  • Should have very good technical problem solving skills
  • Any Salesforce.com certification is preferred
  • Knowledge of Informatica & SQL Database is preffered

For consideration, please send resume to career@infoquestgroup.com


+ API Gateway Developer

Duration & Type: 6+ months Contract with a major financial services firm

Location: Reston, Virginia

Required:

  • 6+ years of hands on Development experience with JAVA, J2EE (Spring, JPA/Hibernate) and REST/SOAP Web Services
  • 2+ years of hands on Development experience working with APIs and API Gateway product. Building API Proxies and API Policies
  • Hands-on experience working on various technologies such as Spring, Hibernate, JPA, Tomcat, Spring Boot, Spring Data, RESTful Architectures, XML, JSON, Java, JavaScript, Tibco BusinessWorks
  • Must have experience with Service Oriented Architecture and Asynchronous designs patterns
  • Must have experience with one or more areas such as Log Analysis using ELK (or Splunk), AWS Cloud
  • Experience with DevOps culture and tools such as Jenkins for CI/CD
  • Cloud experience is a plus (AWS services)
  • Knowledge of (SDLC) software methodologies (e.g., SCRUM/Agile, Waterfall); Agile development is preferred
  • Familiarity with basic networking and infrastructure design principles and SOA Principles – Building scalable Services and API’s is desired
  • Understanding of Architecture and design patterns, best code practices, defensive programming and able to write framework level code
  • Unix Shell scripting experience will be a big plus

For consideration, please send resume to career@infoquestgroup.com


+ API Gateway Engineer

Duration & Type: 6+ months Contract with a major financial services firm

Location: Reston, Virginia

Responsibilities:

  • Help clients with digital transformation through API Management and API Security.
  • Architect solutions with clients, based on best practices.
  • Engineer API security policies and configure API Management.
  • Deploy, configure, tune and monitor API Gateways.
  • Deliver on-site and remote training to partners and customers.
  • Produce customer-facing technical documentation.
  • Assist technical support in troubleshooting customer issues.
  • Develop and maintain training and workshop material.
  • Collect and articulate customer feature requests to Development organization.

Required Qualifications:

  • Minimum of two years experience with any API Gateway
  • Gateway deployment and configuration
  • Policy Development
  • Debugging and troubleshooting
  • Policy Migration
  • Knowledge of Web APIs, REST, XML, JSON, SOA/Web services, Internet/network security standards (WS Security, OAUTH, OpenID Connect, JWT, etc)
  • Proficient with PKI, SSL and SSH security implementations
  • Proficient with Linux OS – Enough to deploy the gateway, install additional client applications, monitor system resources, etc
  • Degree in computer science, computer/software engineering or related discipline – or an equivalent combination of education and experience.

Ideal Qualifications:

  • Experience with: MySQL, Identity and access management systems (LDAP, CA Siteminder, Oracle Access Manager); reliable messaging systems (JMS, WebsphereMQ, Tibco EMS); network infrastructure devices (switches, routers, load balancers); Single Sign On and delegated access technologies (SAML, Kerberos, OAuth and OpenID Connect), Apache Web Server
  • Previous experience programming with OS-level scripting (bash), XML transformations (XPATH and XSLT) and JAVA coding language.
  • Experience with Axway API gateway
  • Experience with virtualized environments (VMware Server, VMware ESX/vSphere) and Cloud-based images (Amazon AMI).

For consideration, please send resume to career@infoquestgroup.com


+ Application Security Specialist

Duration & Type: 6+ months Contract with a major pharmaceutical client

Please Note: This is a W-2 only position, Corp-to-Corp candidates will not be considered for this role.

Location: Cambridge, Massachusetts

Roles & Responsibilities:

  • Create application security related policies & processes
  • Create RFP for selecting a service provider for application security
  • Analyse RFP results and presenting to stakeholders
  • Coordinate vendor product demonstrations and presentations
  • Analyse application security products from various vendors
  • Conduct pilot or POC with selected vendors for threat modeling, architecture reviews, code scanning and penetration testing
  • Collaborate with cross-functional teams and getting their buy-in
  • Manage project deadlines

Required:

  • Experience with compliance and security requirements[AR1] related to medical devices, including data privacy.
  • Knowledge of (information) risk management related standards or frameworks such as COSO, ISO 2700x, CobiT, ISO 24762, BS 25999, NIST, ISF Standard of Good Practice and ITIL
  • Knowledge of OWASP, SDLC, Encryption, Identity and Access Management, data integrity measures
  • Capability to design application security related policies and processes
  • Deep knowledge of integration between Security and system development life cycle
  • 10+ years of working experience, 3+ years as an IT security expert
  • Broad and in-depth technical, analytical and conceptual skills
  • Experience in reporting to and communicating with senior level management
  • Ability to communicate information risk-related concepts to technical as well as nontechnical audiences, and to audiences with a risk management profile as well as those with a less outspoken risk management profile
  • Excellent understanding and knowledge of general IT infrastructure technology, systems and management processes, Application Security, Application Architecture
  • Good mediation and facilitation skills
  • Good knowledge of IT Project Management
  • Proven experience to create new processes or improve existing process
  • Understanding of OWASP top 10 and SANS 25
  • Undergrad in Computer Science or relevant is required, Masters degree is preferred
  • Professional information security certification, such as CISSP, CISM or ISO 27001 auditor/practitioner is preferred
  • Professional (information system) risk or audit certification such as CIA, CISA or CRISC is preferred
  • For consideration, please send resume to career@infoquestgroup.com


    + Oracle DBA

    Duration & Type: 12 months Contract with a major financial services firm

    Location: Reston, Virginia

    Description: An experienced Oracle DBA is needed for a long term project.

    Required:

    • 6+ years of Oracle Administration
    • Must have skills required for Oracle DBA :
      • Performance Tuning
      • Installation/Configuration
      • Data Card
      • Trouble Shooting
      • Experience on Upgrades to recent versions
      • Unix Shell Scripts
      • Import/Export
      • Backup/Recovery (Rman)
      • Exposure/experience to Golden gate
    • Recent hands on working experience on Sybase, or AWS, Postgres will be preferred.
    • Must be good at Performance Tuning

    For consideration, please send resume to career@infoquestgroup.com



    + Performance Tester/Engineer

    Duration & Type: 12 months Contract with a major financial services firm

    Location: Reston, Virginia

    Description:

    An experienced Performance Tester/Engineer with ability to lead the test effort is needed for a long term project.

    Responsibilities:

    • Collect Performance Requirements and transform them to a Test Plan
    • Develop and enhance Truclient ( Web and Mobile ), Web (HTTP/HTML) scripts in loadrunner 12.x from the scenarios identified during the Business meeting with Customer. Other protocols might be required as needed.
    • Understand the environment scaling for QA and Production.
    • Create, Setup Project in Performance Center for new Projects. PC Admin role and responsibilities are required to manage Project in Performance Center.
    • Design Tests in Performance Center 12.x and execute them as required.
    • Setup Monitoring in HP Sitescope(11.3x) and/or  Windows Perfmon for Performance Monitoring.

    Required:

    • 7+ years of overall experience in performance testing
    • Expert on performance testing of web applications, Java, .Net, AJAX, Web services.
    • Experience in developing Test Strategies, Test Cases and Test Procedures from System/Software Requirement specifications and Business Requirements
    • Experience in system testing, Integration testing, Module testing, Sanity testing and Regression testing
    • Experience on tools such as HP Loadrunner & HP Performance Center
    • Experience in performance monitoring tools such as HP SiteScope, HTTPWatch,
    • Knowledge on gathering production metrics from monitoring tools
    • Proficient in writing Performance test plans and strategic documents

    For consideration, please send resume to career@infoquestgroup.com



    + Performance Test Engineer

    Duration & Type: Permanent Full Time job with a major IT services firm

      Only Green Card Holder or US Citizen will be considered for this role.

    Location: Plano, Texas

    Qualifications:

      Basic

    • Bachelor’s degree or foreign equivalent required from an accredited institution. Will also consider three years of progressive experience in the specialty in lieu of every year of education.
    • At least 4 years of experience with Information Technology
      Preferred
  • 4 years of experience in test execution analysis & reporting
  • 4 years of experience in Performance Testing & Engineering activities
  • Expertise in developing Work Load Patterns, Estimations, Develop Performance Strategy and implement them.
  • At least 4 years of experience in test strategy and test Design
  • At least 4 years of experience in test execution analysis & reporting.
  • Strong expertise in load test tools – HP Performance Center, RPT, APM tools like Dynatrace, App Dynamics Experience is preferred.
  • Knowledge of Performance trouble shooting (heap dump & thread dump analysis) is preferred.
  • Ability to lead performance optimization efforts with a strong command of complex performance issues and the ability to direct component owners (network, database, appdev, server OS/WAS, storage, etc.) is a plus
  • Should have Mobile performance testing experience
  • Should have strong coordination, communication & reporting, analytical skills
  • Should have Strong leadership skills
  • Should have experience in Agile and DevOps methodology, micro services, Angular js etc
  • Ability to work in team in diverse/ multiple stakeholder environments
  • Analytical skills
  • Experience and desire to work in a Global delivery environment
  • Travel may be required as per the job requirements.
  • For consideration, please send resume to career@infoquestgroup.com



    + Biostatistician

    Duration & Type: 4 months Contract with a major Pharma client

    Location: Emeryville, California

    Description:

    The Biostatistician will be responsible for providing statistical consultation and advice in quantitative/statistical issues in support of R&D, manufacture, and quality operations of the company.

    Responsibilities:

    • Review protocols and develop appropriate statistical design and analysis plan.
    • Write statistical analysis reports, document the work in compliance with policies and regulations.
    • Provide the necessary input for productive collaboration with R&D scientists and Quality organization.
    • Work with project teams to produce protocols, analysis plans and final reports for clinical and nonclinical projects.
    • Plan, coordinate and produce statistical analyses, summaries and write formal memoranda.
    • Produce SAS programming and other software package programming to analyze data.
    • Interpret the project implications of regulatory guidelines. Interact with FDA, other regulatory or auditing agencies as appropriate in statistical aspects of study design, data analysis, and justification of statistical procedures.
    • Represent Biostatistics on company-wide project teams. Serve as primary liaison between Biostatistics and key internal clients with regard to resource needs and timelines.
    • If appropriate, interact with counterparts at companies collaborating with other Teams including proactively engaging with joint development corporate partners.
    • Initiate methodological research in statistics to improve biostatistics methodology used in developing products consistent with corporate priorities and timelines.
    • Develop Clinical and Nonclinical Biostatistics procedures and guidelines to comply with corporate policies and procedures.

    Required:

    • Must have proficiency as an SAS programmer.
    • Master’s degree in Statistics or Biostatistics with at least two years related experience
    • Minimum 2 years experience in Biostats role within Pharamceutiocal or Diagnostics industry.
    • Minimum 2 years Manufacturing and product development in Pharmaceutical/Biotechnology industry experience (assay validation, product specification setting, OOS, SPC, process optimization, etc.).
    • Minimum 2 years experience managing people in a Biostats or clinical capacity.
    • Demonstrated sound knowledge of statistical applications to clinical and nonclinical projects.
    • Demonstrated technical expertise across a range of commonly used statistical methodology.
    • Knowledge of appropriate regulations and guidance documents. Broad experience across a range of clinical and nonclinical projects and demonstrated support of diverse client needs.
    • Demonstrated management and leadership skills.
    • Demonstration of innovation by development or novel application of statistical methods.
    • Knowledge of FDA regulations and guidelines is a plus.

    For consideration, please send resume to career@infoquestgroup.com



    + Software Engineer

    Description:

    The contract software engineer will be required to interact with local production personnel as well as other contracted vendors to design, develop, test and deploy software projects in a medical device production environment. The contract software engineer will be assisting in our efforts to upgrade Windows XP systems and the custom written VB.Net forms applications to Windows 7 or higher.

    Duration & Type: 3+ months contract with a major Pharma Client

    Location: Huntington, WV

    Responsibilities: The contract software engineer’s list of duties will include, but not be limited to –

    • Completing software changes made to our production applications written in VB.Net related to Windows XP to Windows 7 upgrades
    • Troubleshooting/debugging upgrades to our production applications written in VB.Net related to Windows XP to Windows 7 upgrades
    • Assisting in projects by other vendors to upgrade our production applications written in VB.Net from Windows XP to Windows 10
    • Technical assistance for validation efforts of Windows XP to Windows 7 upgrades
    • Converting SQL Server Reports from version 2005 to version 2016
    • Converting VB.net libraries to C# code using latest coding methodologies

    Required:

    • 5-1 O years’ experience
    • Good troubleshooting and debugging skills
    • Strong VB.net skills a. Object Oriented technology b. Threads c. Forms
    • MS SQL Server Experience (v2005 – v2016) a. SQL b. Stored Procedures c. SSRS – Reports d. SSMS – MS SQL Server Management Studio
    • Experience in C#.net programming language
    • Experience with Entity-Framework
    • WPF experience a plus
    • Windows 7 – 10 experience
    • Visual Studio 2010 – 2015
    • Good Communications skills both written and oral
    • Good troubleshooting skills
    • Some work in “Controlled Environment” room

    For consideration, please send resume to career@infoquestgroup.com


    + Sr. IT Service Manager (GxMP)

    Description:

    This is a Senior role empowered to make decisions. Need someone with minimum 5 to 10 years of business/IT/service management/infrastructure management experience that includes experience in GMP/cGMP production environment.

    Duration & Type: 12 months Contract with a major Pharma Client

    Location: East Hanover, New Jersey

    Major Responsibilities:

    • Business process for Quality and lab functions and MFG across Dev and TO, including Infrastructure and Service management.
    • Support tactical work for business and development with N-2/N-3 strategic plans
    • Manage OCA & GxP
    • Support Stakeholders for business specific to site leadership around Development, MS&T, QA, QC and manufacturing functions
    • Owns processes related to QA/QC covering TechOps and Development and MES covering TechOps across MFG and Quality/QC.
    • Work directly with SDM QC & Analytical testing, CGT or MES N-2/N-3 for TOQ IT and DIT.
    • Support of Production with impact across the 6 change dimensions (process, organization, location, data, application, technology).

    Required:

    • Expert/Proven business process analysis & design, AM and sys arch
    • Practical/technical knowledge of Lab systems, operations & support (LIMS).
    • Management skills for operations changes including financial control & monitoring.
    • Communication & Influential skills

    For consideration, please send resume to career@infoquestgroup.com


    + Architect - Active Directory

    Description:

    Provide complete oversight of entire AD architecture life cycle.

    Duration & Type: 12 Months Contract with a major Pharma Client

    Location: Cambridge, Massachusetts

    Major Responsibilities:

    • Lead the evaluation, design and development of AD technical requirements, solutions, and implementation roadmap to ensure functional, reliable, secure and cost effective technology environment.
    • Analyse business requirements in collaboration with various stakeholders and effectively translate these into functional requirements of the target solution, which should remain in line with Company’s information security strategy and standards.
    • Work across business and IT teams to analyze and define requirements for AD integrations.
    • Lead and /or support associated programs, ensure required processes, procedures, system design documentation are developed and implemented.
    • Provide to global project and operational teams technical advice, guidance, expertise and risk analysis as well as support with remediation requirements.
    • Contribute to the development of overall technical strategies, designs, standards and procedures that support business strategies.
    • Effectively liaise with other teams in information security & risk management, infrastructure & architecture management as well as business functions to deliver the target technology environment and contribute to IT objectives.
    • Strongly promote and advocate AD architecture principles and practices.
    • Define and report to Security Architect IAM technology issues, trends, risks and leading practices.
    • Deliver AD solution utilizing internal and external resources in a matrix organization

    For consideration, please send resume to career@infoquestgroup.com


    + IT Portfolio Service Delivery Expert

    Description:

    The IT Portfolio Service Delivery Expert is responsible for implementing practices within the IT Project & Portfolio management community and monitoring Project Portfolio reports which go upstream to the senior IT Leadership, and via the Demand & Supply Managers, PMs and Service Delivery Leads across all IT Units.

    Duration & Type: 12 Months Contract with a major Pharma Client

    Location: East Hanover, New Jersey

    Major Responsibilities:

    • Supporting the 2018 Portfolio Budget Process
    • Assessing Portfolio Changes
    • Communicating processes to IT Functions
    • Designing requirement and working with IT Functions to ensure practices are well communicated and understood.
    • Responsible for collecting and implementation of feedback from the functions for the practice monitoring, measurement and steering of the execution activities across IT (i.e. metrics definition, monitoring and analysis of practices execution.
    • Support executing central practice activities as per the defined frequency (ex. Portfolio Reviews to CIO, ITIC bi-weekly execution), including core activities e.g. meeting facilitation, minutes, action log, coordination with functions
    • Review Portfolio forecasts, demand, assess portfolio value

    Required:

    • Degree in Information, Computer Science or Life Sciences
    • Proven portfolio management knowledge and project management experience (5 years min)
    • Proven experience in project budgeting with experience in project financial processes and systems
    • Strong analytical skills and high degree of detailed oriented working style
    • Excellent interpersonal (verbal and written) communication skills to support working in project environments that includes internal, external and customer teams.
    • Fluent in English – oral and written
    • Strong process creation and ownership experience
    • Ability to manage multiple priorities and assess and adjust quickly to changing priorities
    • Experience with Clarity or similar PPM tools, Excel, macros

    For consideration, please send resume to career@infoquestgroup.com


    + Senior SAP Analyst


    Position Description

    Functional Analysis, systems support and Information System (IS) consulting to Applications development and systems implementation initiatives; Deliver measurable business value contributions to the implementation of IT solutions that support various areas of commercial operations; Work with Client/IS management to identify and specify complex business requirements and provide IT recommendations and solutions; Define systems strategy, developed systems requirements, design and prototype, test, provide training, define support procedures, and implement practical business solutions; Design, develop, test, implement, and maintain enhancements to existing applications using SAP R/3 modules focusing on Sales & Distribution(SD), Material Management(MM), Production Planning(PP), Finance and Controlling(FICO), Vendor Invoice Management(VIM), VIA 2; Research and evaluate alternative solutions, make recommendations for process improvement; Plan and coordinate systems changes with customers, managing application downtime; Review, analyze and modify programming systems including encoding, testing, debugging, and installing to support Client’s applications systems; and Consult with users to identify current operating procedures and clarify program objectives; provide training, support, and documentation in the installation of new systems, enhancements and modifications. Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations. Tools: SAP-ABAP/CRM, Logistics (SD, MM, PP, QM, PM AND CS), Financials (FI, CO, CO-PA), WEB UI, SharePoint, Solution Manager tools, VirtualForg, C, VB, RFC programming, RF Gun, ALE and IDOCs, LSMW data loads and BDC programming, SAP User Exits, Smart Forms, Scripts and LSMW, ERP, SAP CRM.

    Education: Master’s in Computer Science/Applications/Engineering (Electronics/ Mechanical/Civil/Electrical), MIS, MBA. Will accept Bachelor degree in Computer Science, Applications, Engineering (Electronics/Mechanical/Civil/ Electrical) followed by five years of progressive experience in field or related field in lieu of Masters. Will accept foreign education equivalent.

    For consideration, please send resume to career@infoquestgroup.com


    + Software Developer

    Position Description

    Create and formulate technical design from the functional design; provide support and enhancements per user requests; Unit Test configuration; Migrate Data into the newly created/ modified data Model; Analyze report designs given by clients and provide feedback on defects and missing criteria; maintain system interfaces, design for scalability and modularity, support platform-level architecture and future development; Identify software and hardware components to implement IT infrastructure of organization; build prototypes, design software components, develop and integrate modules into a complete system, architect, design, develop, enhance various components of software platforms to host carrier grade enterprise applications; perform unit tests; troubleshoot problems; perform thread analysis, code profiling and optimization using one or more of the following languages, tools, hardware and equipment; Create Oracle stored Procedures for achieving business requirement and testing data; design Low Level Design, created Data Models and target table structures; Develop the test strategy for QA; Tested Siebel Scripts, Fix Bugs / defects in the system; Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations.
    Tools: Siebel eBusiness Application, Siebel Configuration, Scripting, COM Integration and Siebel Data Quality, Oracle CRM On Demand (SaaS), Salesforce.com; Oracle, MS SQL Server, Windows, Siebel Tools, SQL, PL/SQL Developer Kit, VM Ware, Snagit, C, C++, Java. VB, Siebel (Call Center, HTIM, eService).

    Education: Bachelor degree in Computer Science, Applications, Engineering (Electronics/Mechanical/Civil/ Electrical) plus 2 years of experience. Will accept three year bachelors in computer science followed by three years of experience in development, analysis, integration, data migration. Will accept foreign education equivalent.

    For consideration, please send resume to career@infoquestgroup.com


    + Software Developer

    Position Description

    Create and formulate technical design from the functional design; provide support and enhancements per user requests; Unit Test configuration; Migrate Data into the newly created/ modified data Model; Analyze report designs given by clients and provide feedback on defects and missing criteria; maintain system interfaces, design for scalability and modularity, support platform-level architecture and future development; Identify software and hardware components to implement IT infrastructure of organization; build prototypes, design software components, develop and integrate modules into a complete system, architect, design, develop, enhance various components of software platforms to host carrier grade enterprise applications; perform unit tests; troubleshoot problems; perform thread analysis, code profiling and optimization using one or more of the following languages, tools, hardware and equipment; Design & Develop Complex and efficient Informatica mappings; Create Oracle stored Procedures for achieving business requirement and testing data; design Low Level Design, created Data Models and target table structures; Develop the test strategy for QA; conduct tool evaluation; develop test cases for Informatica testing; Tested Siebel Scripts, Fix Bugs / defects in the system, develop processes to achieve standardization of code and process. Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations. Tools: CRM-Siebel eBusiness Application, Oracle CRM On Demand (SaaS), Salesforce.com; Oracle Business Intelligence; Oracle, MS SQL Server; Operating System: Windows; Tools: Siebel Tools, PL/SQL Developer kit, VM Ware, Snagit; C, C++, Java; Integration: Cast Iron Integration Studio, Talend Open Source Data Integration 4, Informatica Cloud.

    Education: Bachelor degree in Computer Science, Applications, Engineering (Electronics/Mechanical/Civil/ Electrical) plus 2 years of experience. Will accept three year bachelors in computer science followed by three years of experience in development, analysis, integration, data migration. Will accept foreign education equivalent.

    For consideration, please send resume to career@infoquestgroup.com


    + Senior SAP Analyst

    Position Description

    Functional Analysis, systems support and Information System (IS) consulting to Applications development and systems implementation initiatives; Deliver measurable business value contributions to the implementation of IT solutions that support various areas of commercial operations; Work with Client/IS management to identify and specify complex business requirements and provide IT recommendations and solutions; Define systems strategy, developed systems requirements, design and prototype, test, provide training, define support procedures, and implement practical business solutions; Design, develop, test, implement, and maintain enhancements to existing applications using SAP R/3 modules focusing on Sales & Distribution(SD), Material Management(MM), Production Planning(PP), Finance and Controlling(FICO), Vendor Invoice Management(VIM), VIA 2; Research and evaluate alternative solutions, make recommendations for process improvement; Plan and coordinate systems changes with customers, managing application downtime; Review, analyze and modify programming systems including encoding, testing, debugging, and installing to support Client’s applications systems; and Consult with users to identify current operating procedures and clarify program objectives; provide training, support, and documentation in the installation of new systems, enhancements and modifications. Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations. Tools: Visual Basic, Oracle, Factiva, OneSource Business Browsers, ISI Emerging Markets, Thomson Research, Dow Jones, Gartner (with AMR), Kennedy Information, Forrester, Prowess, EIU, SCRUM,SAP ECC, SAP HANA MS Office, MS Projects,Req Pro Deloitte EVM Tools, Ajax, PHP, HTML, ABAP, C, C++, Java, Visual Basic, Oracle 9i,SQL, MYSQL, Dream Weaver, Ajax, Php, Javascript, My Sql, Dream Weaver, MS-Project, MS-Excel, MS-PowerPoint.

    Education: Master’s Degree in Computer Science, Applications, Engineering (Computer, Electronics/Mechanical/Civil/ Electrical). Will accept a Bachelor’s degree followed by five years of progressive experience. Will accept foreign education equivalent.

    For consideration, please send resume to career@infoquestgroup.com


    + Senior SAP Analyst

    Position Description

    Functional Analysis, systems support and Information System (IS) consulting to Applications development and systems implementation initiatives; Deliver measurable business value contributions to the implementation of IT solutions that support various areas of commercial operations; Work with Client/IS management to identify and specify complex business requirements and provide IT recommendations and solutions; Define systems strategy, developed systems requirements, design and prototype, test, provide training, define support procedures, and implement practical business solutions; Design, develop, test, implement, and maintain enhancements to existing applications using SAP R/3 modules focusing on Sales & Distribution(SD), Material Management(MM), Production Planning(PP), Finance and Controlling(FICO), Vendor Invoice Management(VIM), VIA 2; Research and evaluate alternative solutions, make recommendations for process improvement; Plan and coordinate systems changes with customers, managing application downtime; Review, analyze and modify programming systems including encoding, testing, debugging, and installing to support Client’s applications systems; and Consult with users to identify current operating procedures and clarify program objectives; provide training, support, and documentation in the installation of new systems, enhancements and modifications. Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations. Tools: ABAP/4 – Reports, Dialog, Report Painter/Writer, Menu/Field/Function Exits, Data Conversions, Interfaces, BDCs, BAPI’s, BADIs, RFC, ALE, IDoc, LSMW, CATT, Layout Sets, User Exits, OSS, Domains, Data Elements, SAP Script, Smart Forms, Workflow, XI/PI; ABAP objects, Java, SQL, Basic, C, C ++, VC ++, Java Script, VB; MS-Office, FrontPage; Oracle, SQL Server, MS Access; ETL Informatica, TCP/IP, OSI model; Windows, MS-DOS, Unix and LINUX, Agile/Waterfall Methodologies.

    Education: Master’s in Computer Science/Applications/Engineering (Electronics/ Mechanical/Civil/Electrical), MIS, MBA. Will accept Bachelor degree in Computer Science, Applications, Engineering (Electronics/Mechanical/Civil/ Electrical) followed by five years of progressive experience in field or related field in lieu of Masters. Will accept foreign education equivalent.

    For consideration, please send resume to career@infoquestgroup.com


    + Test Analyst

    Duration & Type: Permanent/Fulltime position with a client

    Note: No Visa sponsorship available for this role. Hence, only US Citizen or Green Card holder will be considered for this role.

    Location: Roseville, CA

    Description:

    As a Test Analyst, you will be responsible for reviewing assigned change request documentation to understand the details about what needs to be tested (requirements, design, features, impacts to other application components, notices, reports, forms, interfaces); and deciding how best to approach and design the test, based on in the change request document review.

    Responsibilities:

    • Executing tests, recording deficiencies found and escalating for correction;
    • Reviewing defect fixes and conducting retests to ensure satisfactory resolution;
    • Ensuring all test-related work is conducted in accordance with defined standards and procedures
    • Following appropriate problem escalation and resolution procedures.

    Required:

    • Experience with Selenium and automated testing.
    • 2 years’ experience Test Planning. Design and Execution
    • 2 yrs Experience with Health and Human Services systems projects (State or Federal govt experience is added advantage)
    • Must have excellent oral and written communication skills.
    • Automation Testing experience is added advantage

    For consideration, please send resume to career@infoquestgroup.com


    + Technical Test Lead – API Testing + DevOps

    Duration & Type: Permanent/Fulltime position with a client

    Note: No Visa sponsorship available for this role. Hence, only US Citizen or Green Card holder will be considered for this role.

    Location: Rosemead, CA 91770

    Required:

    • At least 4 years of experience in IT industry
    • Good knowledge of Devops methodology and should be able to create Test Strategy and Plans
    • In depth knowledge of DevOps testing, enabling early and automated verification of build as well as continuous integration of the progressive automation suite.
    • Working knowledge of SOA Testing: Business scenario driven testing, Stubs, Functional, PT and regression testing
    • Utility company experience
    • Experienced in testing methodologies and testing processes
    • Excellent analytical and problem-solving skills
    • Excellent knowledge of PC based Microsoft Office applications, including; MS Word, Project, Excel, PowerPoint, etc.
    • Ability to handle and resolve conflicts
    • Excellent interpersonal skills conducive to working in a team environment across all skill levels and departments
    • Ability to facilitate and negotiate between departments/divisions
    • Ability to regularly exercises discretion and independent judgment the in the performance of his/her job duties.
    • Strong written and verbal communication skills
    • Ability to multi-task and prioritize
    • Self-motivated and proactive
    • Able to drive results while maintaining a collaborative and respectful environment
    • Experience in completing multiple assignments simultaneously, working well under pressure, and adjusting to changing priorities
    • Experience in supporting project teams and interfacing with various organizations to resolve testing issues
    • Ability to analyze, perform, and validate test scenarios when needed
    • Experience in test management tools such as HP ALM
    • Communication and Analytical skills
    • Experience and desire to work in a Global delivery environment

    For consideration, please send resume to career@infoquestgroup.com


    + DevOps Tester

    Duration & Type: Permanent/Fulltime position with a client

    Note: No Visa sponsorship available for this role. Hence, only US Citizen or Green Card holder will be considered for this role.

    Location: Rosemead, CA 91770

    Responsibilities:

    • Ensure requirements traceability by mapping all test cases to system requirements.
    • Follow established testing processes and procedures as outlined for system under test.
    • Review test cases based on technical requirements with detail steps and expected results.
    • Review test data including the execution of test scripts and use cases and verification of output.
    • Conduct and track functional, system and regression testing activities for all applications in support of the project.
    • Analyze test results, record and track issues/defects found, conducts regression testing if required.
    • Review defects when test cases fail, with step by steps details to reproduce the defect.
    • Document and manage test plans, test cases, defects, and trace them in HP-ALM.

    Required:

    • Experience with test management tools such as HP ALM
    • Should have in-depth knowledge of DevOps testing, enabling early and automated verification of build as well as the continuous integration of the progressive automation suite.
    • Should be able to develop test Strategy and test plans
    • Should be able to develop and manage test cases to have full test coverage of all requirements for project
    • Experience and desire to work in a management consulting environment that requires regular travel
    • Excellent knowledge of PC based Microsoft Office applications, including; MS Word, Project, Excel, PowerPoint, etc.
    • Excellent interpersonal skills conducive to working in a team environment across all skill levels and departments
    • Ability to facilitate and negotiate between departments/divisions
    • Ability to regularly exercises discretion and independent judgment the in the performance of his/her job duties.
    • Strong written and verbal communication skills
    • Ability to multi-task and prioritize
    • Able to drive results while maintaining a collaborative and respectful environment
    • Experience completing multiple assignments simultaneously, working well under pressure, and adjusting to changing priorities
    • Experience supporting project teams and interfacing with various organizations to resolve testing issues

    For consideration, please send resume to career@infoquestgroup.com





    + Principal Safety Scientist


    Duration & Type: 6 months Contract with a major pharmaceutical client

    Location: Fort Worth, Texas

    Responsibilities:

    • Contribute to the establishment of a complete list of Device products
    • Review product listings and provide medical/scientific input to define product hierarchy
    • Conduct data search on assigned products from literature, technical documents, and other sources
    • Evaluate safety information and support safety team deliverables
    • Ensure timely communication of identified issues and potential impact to project team
    • Collaborate productively with project team and external stakeholders to resolve identified issues

    Required:

    • Clinical and technical expertise in ophthalmic medical devices
    • Proficient in Microsoft Office
    • Ability to work independently and meet targeted timelines
    • Good written and verbal communication
    • Attention to detail, strategic thinking and problem solving skills
    • Experience in preparing or contributing to regulatory reports/submissions involving safety information

    For consideration, please send resume to career@infoquestgroup.com



    + Sr. Safety Lead


    Duration & Type: 6 months Contract

    Location: Fort Worth, Texas

    Responsibilities:

    • Perform single case medical review in the safety database or line listings
    • Provide guidance for coding, causality assessment, and determination of anticipated vs. unanticipated adverse event reports
    • Monitor the clinical safety of assigned products/projects, including literature review, adverse events, patient impact from technical complaints
    • Provide safety input into clinical and regulatory deliverables, including Investigator’s Brochures, study protocols, reports, and clinical submission documents
    • Identify safety signals based on the review of solicited or unsolicited single cases.
    • Perform signal triage activities, evaluation, and presentations
    • Author the safety profiling and risk management documents
    • Lead cross-functional projects and support the Safety Management Team

    Required:

    • At least 4 years of industry experience in product development, clinical trial methodology, and regulatory requirements (preferred)
    • Proven ability to analyze, interpret, and discuss safety information
    • Excellent written and verbal communication skills
    • Education: Ophthalmologist
    • Optometrist with extensive knowledge in ophthalmic surgeries may be considered

    For consideration, please send resume to career@infoquestgroup.com



    + Associate Scientist II

    Duration & Type: 6+ months Contract with our client – a global leader in the pharmaceutical industry

    No. of Positions: 1

    Location: East Hanover, New Jersey

    Responsibilities:

    • Perform a variety of chemical analyses on drug product samples in support of the company’s stability program.
    • Interpret and evaluate test data in terms of accuracy and precision.
    • Under the guidance of the manager conduct laboratory investigations and resolve technical problems.
    • Follow established company procedures and cGMPs.
    • Contribute to milestones for specific quality assurance projects.

    Required:

    • BS degree in Chemistry or related discipline
    • 5-8 years experience in a regulated laboratory setting
    • Experienced in analytical instrumentation such as HPLC, GC, and UV/Vis Spectrophotometry
    • Excellent oral and written communication skills

    For consideration, please send resume to career@infoquestgroup.com


    + Clinical Research Scientist II

    Duration & Type: 6+ months Contract with our client – a global leader in the pharmaceutical industry

    No. of Positions: 1

    Location: East Hanover, New Jersey

    Description:

    The Clinical Research Scientist (CRS) will support US efforts in the planning, execution, and reporting of US CD&MA clinical trials in Oncology/Hematology, with an emphasis on CAR-T.

    Responsibilities:

    • Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial-related documentation (protocols, Case report forms, consent documents, letters of agreement, confidentiality agreements), and organizing Ethics committee submissions.
    • Track and manage key trial indicators including monthly project status, key deliverables to senior management.
    • Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems.
    • Serve as U.S. Local trial lead for multiple global clinical development trials and/or non- registration U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use).
    • Interface with the oncology therapeutic area global and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, finance, quality, compliance, and other relevant functional areas.
    • Liaise with study investigators, site research staff, and field based colleagues to support clinical studies.
    • Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
    • Organize investigator’s start-up meeting and study site initiation meetings.
    • Drive study enrollment, plan advisory boards and perform external study feasibility with investigators.
    • Patient Recruitment: track enrollment, develop recruitment plans, and ensure procedures are in place for appropriate optimization of patients into the clinical trial.
    • Manage patient recruitment strategies to increase patient randomization into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs).
    • Understand and comply with company SOPs and GCP’s; contribute to continuous improvement in SOPs and local Working Practices.
    • Plan the requirements for clinical trial (CT) material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby material is shipped to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
    • Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
    • Contribute to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency.
    • Support the development, management, and tracking of trial budgets working closely with the appropriate partners.
    • Maintain project files including ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions, etc.

    Required:

    • Bachelor’s degree in a science-related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
    • 3-5 years of experience – Experience in CAR-T cell therapy preferred.
    • Significant clinical research or research monitoring experience that provides the required knowledge, skills and abilities and experience mentoring or training others.

      Note: In some cases, an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

    • Effective clinical monitoring skills.
    • Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practices, and applicable Standard Operating Procedures.
    • Ability to mentor and train other monitors in a positive and effective manner.
    • Ability to evaluate medical research data and proficient knowledge of medical terminology.
    • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
    • Strong customer focus.
    • Excellent interpersonal skills.
    • Strong attention to detail.
    • Effective organizational and time management skills.
    • Proven flexibility and adaptability.
    • Excellent team player with team building skills.
    • Ability to work independently as required.
    • Ability to utilize problem-solving techniques applicable to constantly changing environment.
    • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.
    • Good English language and grammar skills.
    • Effective presentation skills

    For consideration, please send resume to career@infoquestgroup.com

    + Associate Manager - Regulatory CMC

    Duration & Type: 12 months Contract with with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Description:

    The Associate Manager – Regulatory CMC will independently manage or assist and support regulatory CMC managers in the following activities:

    • Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.
    • Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product lifecycle, to project teams and appropriate management levels within and outside of Reg CMC
    • Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making
    • Single point of contact with other line functions
    • Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met
    • Collecting documentation from other line functions to support submission preparation
    • Ensure databases are maintained to compliance

    Required:

    • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
    • Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
    • 2-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
    • Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
    • Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines
    • Knowledge/experience of regulations, guidelines for NCEs and product lifecycle maintenance desirable
    • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
    • Effective planning, organizational and interpersonal skills
    • Reasonable approach to risk assessment
    • Excellent written/spoken communication and negotiation skills
    • Computer literacy

    For consideration, please send resume to career@infoquestgroup.com


    + Associate Clinical Development Director

    Duration & Type: 9 months Contract with with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Description:

    The Associate Clinical Development Director is responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. May be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.

    Responsibilities:

    • Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP)
    • Develops materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Company local medical organizations
    • Provides clinical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
    • In collaboration with appropriate Clinical Trial Team (CTT) members:
      • (a) Ensures clinical support of trials as needed
      • (b) Conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
      • (c) Manages patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead
      • (d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
    • Supports Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs
    • Supports development of TA strategies, as needed
    • May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities
    • Contributes to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develops and fosters CD culture; and may contribute to the performance evaluation of CTT members
    • Contributes to medical/scientific training of relevant Company stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
    • Contributes to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

    Required:

    • 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
    • 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g. planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
    • Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
    • Demonstrated ability to establish effective working relationship with key investigators
    • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
    • Strong communication skills, written and oral; Strong interpersonal skills; Strong negotiation and conflict resolution skills
    • Proven ability to work independently or in a cross-functional team setting
    • Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
    • PharmD, or PhD strongly preferred

    For consideration, please send resume to career@infoquestgroup.com


    + Regional Site Managers (CRAs)

    Duration & Type: 12 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Remote Position

    PLEASE NOTE: The candidate must be living in one of the NORTHEAST or NORTHWEST States of the US.

    Description:

    Regional Site Managers (CRAs) are needed to support the goals of the GenMed organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Company SOPs and ensuring that the study milestones are met; and to be a central point of communication between Company and investigational sites for all GenMed clinical trial related activities.

    Major Accountabilities:

    • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
    • Ensure the site Investigator Folder is up to date and mirrors the Company TMF. Responsible for collecting regulatory documents from site and filing in the Company TMF. Prepare and collect study site documents.
    • Perform Initiation Visit and continue to train study personnel as needed on the study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism.
    • Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in conjunction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
    • Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
    • Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems.
    • Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).
    • Enforce and follow GCP and ICH requirements as appropriate.
    • Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations. May review and approve monitoring reports of junior CRAs as assigned.
    • Manage data query resolution process with sites and track status updates (i.e. IWS).
    • Perform Site Closeout activities per SOPs and applicable regulations.
    • Travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
    • ***A minimum of 50% overnight travel may be required***
    • Attend and participate in disease indication and project specific training and general CRA training as required.

    Required:

    • Minimum of 3-5 years of experience as a CRA.
    • Solid medical and business knowledge.
    • Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.
    • Advanced understanding of clinical development, knowledge, and experience in international (FDA, EMEA, ICH) and local regulations.
    • Excellent oral and written communication and presentation skills.
    • Computer literacy and proficiency.
    • Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.
    • Bachelor’s degree or higher in a scientific or healthcare discipline preferred. A nursing degree or extensive relevant experience may commensurate
    • Certifications & Licenses: PMP
    • Required Skills: Clinical Study, Clinical Trial, Clinical Research, Sae Reporting, Sops, Study Monitoring, Training, Presentation Skills, Regulatory Documentation

    For consideration, please send resume to career@infoquestgroup.com



    + Project Manager III - Clin/Sci

    Description:

    Looking for a Project Manager with Pharma experience to manage the organization/execution of key projects/initiatives within Oncology Medical Affairs (OMA) and Global Medical Affairs (GMA). This is a challenging, high-profile role in a matrix organization with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices.

    Duration & Type:  3+ months of contract our client – a global leader in the pharmaceutical industry

    Location:  East Hanover, New Jersey

    Responsibilities: As the person responsible for the success of the project/initiative, some key responsibilities include but are not limited to –

    • Leading, coordinating and managing multiple OMA/GMA projects/initiatives from conception through completion in accordance with corporate policies and procedures
    • Ensuring all projects/initiatives milestones are on-time and within scope
    • Advising key stakeholders on project/initiative performance using appropriate systems, tools, and techniques
    • Serving as liaison between OMA/GMA, cross-functional business partners, and key stakeholders to monitor and follow up on deliverables
    • Escalating to key stakeholders and mitigating gaps when deliverables are at risk
    • Preparing presentations on project status for senior management
    • Supporting other activities as needed

    Required:

    • Bachelor’s degree required; MA/MS/MBA degree or other advanced degree preferred
    • 5+ years of project management experience in the pharmaceutical and/or biotechnology industries.
    • Exercises strong foresight, judgment and decision making; ability to work well under pressure
    • Organized and detail-oriented with the ability to handle multiple priorities simultaneously
    • Extensive experience with aligning stakeholders, facilitating conflict, and influencing without authority
    • Proven record of accomplishments that demonstrate strong strategic project management, analytical and multi-tasking skills.
    • Strong written and oral communication skills including strong MS Word, Excel and PowerPoint skills

    + Regulatory Affairs Consultant

    Description:

    The Regulatory Affairs (RA) Consultant is a member of the Global Regulatory Leadership Team and the Global Regulatory Strategy Team (GRST) and contributes to the vision and goals for GRA and ensures that the International Regions objectives are aligned with the strategic objectives of GRA and US & Americas Commercial Group. The RA Consultant collaborates and aligns with other Regional Heads, GRA as appropriate and acts as the Regulatory Site Head where the incumbent is located.

    Duration & Type: 9+ months Contract with our client – a global leader in the pharmaceutical industry

    Location: Cambridge, Massachusetts

    Reporting Relationships:

    • Reports to Global Head, Regulatory Affairs
    • Direct reports: Four Manager/Senior Manager roles and up to six indirect reports

    Key responsibilities:

    • Provide leadership, strategic direction and managerial oversight to the US, Canada, and LATAM based regulatory teams to develop and execute regulatory strategies and plans for the region.
    • Interface with other function leads (e.g. R&D Leaders: Clinical Development/Medical Affairs/Safety/Technical Development; Commercial Leaders: Americas & Commercial Development and Quality Operations Leaders such as CQA ) to ensure collaborative connectivity with these key stakeholders, and a focused regional regulatory approach to supporting country and regional business objectives. Can also represent GRA within the region through matrixed involvement with global technical and/or functional GRA departments.
    • The role will have direct responsibility for the Regulatory Affairs consultant support in Canada and will direct strategy with respect to Canadian filings and the interactions with the BGTD.
    • This role is the primary liaison for the company with the FDA, CBER and is responsible for establishing the regulatory credibility for the company, maintaining a relationship with the FDA that facilitates a constructive and collaborative dialogue that enables the timely delivery of regulatory outcomes consistent with the company strategy throughout all stages of the product lifecycle.
    • This role will advise senior and executive management on the regulatory climate and proposed changes in FDA rules and regulations, policies and guidances that could impact the business.

    Required:

    • A degree in Biological or Medical Science or Pharmacy, preferably with a post graduate qualification
    • At least 10 years of regulatory experience, supported by additional pharmaceutical/industry experience
    • Thorough understanding of how regulatory bodies approach dossier reviews, pre-approval and post approval inspections and of how to respond to Health Authority observation is required
    • Extensive experience at a senior level in Regulatory Affairs, with a strong knowledge of regulatory affairs legislation and processes in the US
    • Regional regulatory experience including knowledge of and application submission processes and product life cycle management activities with biological products
    • Demonstrated experience across drug development and commercialization lifecycle, with proven examples of contribution
    • General management experience with line management and leadership at senior management level is essential
    • Demonstrable experience in establishing and building a high performing team essential, and specifically a RA team highly desirable
    • Superior strategic and tactical thinking ability, complemented by a “hands on” operational and business planning orientation
    • A balanced technical understanding of products and processes combined with superior business, regulatory and compliance acumen

    For consideration, please send resume to career@infoquestgroup.com


    + Regional Clinical Research Associate

    Description:

    Seeking a senior professional to serve as a leader and mentor to other CRAs in all aspects of the CRA role. The therapeutic area is Cardiovascular, Respiratory and Ophthalmology.

    Duration & Type: 12 Months Contract with our client – a global leader in the pharmaceutical industry

    Location:  Connecticut

    Responsibilities:

    • Represent RAD and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g. site selection, site issue resolution). May interview prospective CRA candidates and assist with performance evaluation and management of CRAs.
    • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification.
    • Ensure the site Investigator Folder is up to date and mirrors the Company TMF. Responsible for collecting regulatory documents from the site and filing in the Company TMF. Prepare and collect study site documents.
    • Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF (or eCRF) completion, SAE reporting, GCP, and possibly the drug mechanism.
    • Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials. Nominate sites to participate in studies in con- junction with Medical Science Liaison (MSL) and Clinical Research Medical Advisor (CRMA) colleagues.
    • Monitor site drug supply, storage, accountability documentation. Perform interim and final drug return.
    • Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems.
    • Ensure that study milestones are met as planned (i.e. database analyses, study startup, recruitment, closeout, etc.).

    Required:

    • Solid medical and business knowledge.
    • Three to five years of experience as a CRA. Trial Lead CRA experience desirable.
    • Bachelor’s degree or higher in a scientific or health care discipline preferred.
    • A nursing qualification or extensive relevant experience may be acceptable

    For consideration, please send resume to career@infoquestgroup.com


    + Expert Clinical Manager III

    Description:

    Responsible for all operational aspects of one or more OGD clinical trial(s) under the leadership of Clinical Trial Head (CTH). Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned.

    Duration & Type: 6 months Contract with a major Pharma Client

    Location: East Hanover, New Jersey

    Responsibilities:

    • Ensure all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards.
    • Provide input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing.
    • Prepare training materials and presentations related to the planning and conduct of the trial.
    • Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
    • Manage interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and Company’s local medical organizations.
    • Accountable for accuracy of trial information in all trial databases and tracking systems.
    • Support the development, management, and tracking of trial budget working closely with the appropriate partners in OGD.
    • Write CTT meeting minutes. May occasionally deputize for the CTH at Clinical Trial Team meetings. May participate in International Clinical Team meetings.
    • Contribute to program level activities (e.g., tracking of OGD program-related publications, development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions).
    • Contribute to talent and career development of OGD staff through active participation in on-boarding, training and mentoring activities. May serve as faculty member for OGD training programs.

    Required:

    • Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
    • Excellent communication, organization, and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
    • Proven networking skills and ability to train colleagues.
    • Proven ability to work both independently or in a team setting, including a matrix environment
    • Knowledge of Good Clinical Practice; thorough knowledge of clinical trial design; understanding of the overall drug development process.
    • Knowledge of principles for trial budgeting.
    • Basic knowledge of oncology and/or hematology preferable
    • Advanced degree or equivalent education/degree in life science/healthcare required accompanied with 2 years of experience in clinical research or Bachelor degree or equivalent education/degree in life science/healthcare required if accompanied with 4 years of experience in clinical research

    For consideration, please send resume to career@infoquestgroup.com


    + Expert Clinical Manager II

    Description:

    Responsible for operational aspects of one or more clinical trials (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use) under the leadership of the CTH. Support all scientific aspects of clinical trial(s) as assigned. Responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus

    Duration & Type: 6 months Contract with a major Pharma Client

    Location: East Hanover, New Jersey

    Responsibilities:

    • Contributes to or manage simple clinical trial with minimal supervision by providing input and contribute to the development of protocols and related documents, in the ongoing scientific review of clinical data, and in trial data analysis, reporting and publishing. Prepare training materials and presentations related to the planning and conduct of the trial.
    • Manage simple clinical trial under supervision from the senior clinical operations team. Write CTT meeting minutes. May deputize for the CTH at certain meetings. Ensure all assigned operational trial deliverables are met according to timelines, budget, operational procedures and quality standards, SOPs and Business Guidance.
    • Contribute to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing.
    • Assist in preparation of clinical outsourcing specifications. Responsible for management of Contract.
    • Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget
    • Support the development, management and tracking of trial budget working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
    • Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc.
    • Participate in the on-boarding and training of new staff. May serve as faculty member for training programs.
    • Responsible for MRC process as directed by GMA medical lead. Contribute to the management of third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored Novartis Trials – provide feedback on study proposals, review submitted study concepts/protocols for core requirements via the Study Express System. Collaborate with local CPOs and regions to track study progress, update databases and manage budget. Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements
    • Support Individual Patient Support Program as assigned. Manage physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply.
    • Participate in assigned initiatives.

    Required:

    • More than 3 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
    • Proven ability to work independently and ability to collaborate and work effectively in teams
    • Demonstrated ability to support more than one clinical trial.
    • Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required.
    • Basic knowledge of hematology/oncology/endocrinology therapeutic areas is preferred.
    • Degree in health or life sciences.

    For consideration, please send resume to career@infoquestgroup.com


    + Clinical Research Analyst

    Description:

    Coordinate study start-up activities, author protocols, case report forms and sample informed consent as well as assist with investigator selection and investigator meeting coordination. Assist in the review and collection of essential documents. assist with site management, on-going study and study completion activities, including management, training and mentoring of CRO and team CRAs; archive of all study documents; assist in preparation of clinical study reports, investigators brochure and other regulatory documents, writing of reports as needed, and review of tables and listings; Assist in preparing abstracts, publications and other scientific communications; complete assigned clinical development support activities on time and with high degree of quality; track study related activities and documents; document study/site management activities as needed to support GCP, ICH and regulatory guidance; ensure timely communication regarding the reporting and management of serious adverse events, significant findings or issues regarding the conduct of the study; and be responsible for study budget support and adherence with assistance. Perform data analysis, statistical analysis, generate reports, listing and graphs; work with biostatisticians, writers and clinical staff to generate data summarization, analysis and reports and develop applications and reports per requirements; review reports for consistency between texts and tables. Relocation/telecommuting may be required plus travel to various unanticipated client locations within the United States for short and long term durations.

    Location:

    Work location for the above position would be in one of the following areas/states –
    Emeryville, California;
    San Diego County, California;
    Connecticut

    Required: Master’s Degree in Chemistry, Biochemistry, Life Sciences. Will Accept a Bachelor’s degree followed by five years of progressive experience. Will accept foreign education equivalent. HIPAA Certified, OTIS Certified an asset.

    For consideration, please send resume to career@infoquestgroup.com


    + Formulations Scientist

    Description:

    • Plan and perform scientific experiments (or pilot plant processes) for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures in collaboration within a multifunctional project team coordinated by a Project leader. Focus is sterile ophthalmic preparations. Contribute to maintenance of lab instruments/infrastructure.
    • Plan, organize, perform and document scientific experiments/plant activities in collaboration with experienced team members if necessary. Seeks proactively for support and coaching from Project Leader, Scientific Expert or other team members during the whole process if necessary.
    • Plan and perform scientific experiment/plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team members under guidance. (e.g. contribute to interpretation and report results)
    • Provide efficient and robust processes for the manufacture and/or specialized facilities e.g. containment/sterile labs as an expert w/ adequate guidance.
    • Provide raw data documentation, evaluation and results interpretation. Propose and provide input for the design of next experiments.
    • Optimize existing methods (lab or plant) and develop more efficient ones. Generate lab procedures, reports and/or instructions.
    • Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls etc.

    Duration & Type: 12+ months Contract with a major Pharma client

    Location: Fort Worth, Texas

    Required:

    • Minimum of 3 successful years of formulation development experience
    • Prefer MS degree

    For consideration, please send resume to career@infoquestgroup.com


    + Operational Compliance Specialist

    Description:

    The Operational Compliance Specialist is responsible for maintaining full compliance and execution of company policies related to import and export transactions, controlled substances, and other programs. The Specialist provides technical and day-to-day guidance to researchers. Working with the Trade Compliance Manager, the Operational Compliance Specialist is responsible for maintaining the full compliance and execution of import and export transactions conducted by NIBRI and monitoring the completion and maintenance of trade documentation.

    Duration & Type: 18 months Contract with a major Pharma client

    Location: Cambridge, Massachusetts

    Required:

    • Language skills – English (written and spoken), other languages such as German and French would be advantageous
    • Minimum 1-4 years of experience in importing and exporting, preferably in the scientific industry
    • Demonstrated experience in the clearance of import shipments to the U.S., customs brokerage, interactions with brokers and Customs and Border Protection
    • Demonstrated experience with export shipments, including checking for export license requirements and export reporting to US authorities
    • Practical experience applying US Customs regulations, US Export Administration Regulations and license requirements, Harmonized Tariff Schedule, General Rules of Interpretation, INCOTERMS, and brokerage
    • Good written and oral communication skills, collaboration/consensus building, influencing and negotiation skills. Demonstrated ability to successfully work globally and effectuate change within a high-performing organization
    • A clear sense of accountability; used to successfully working in a matrix environment with a high degree of mutual respect and integrity.

    For consideration, please send resume to career@infoquestgroup.com


    + Medical Safety Specialist

    Description:

    • Responsible for day-to-day case management of quality and adverse event complaint records involving Company manufactured products.
    • Complaint handling accountability reflects activities required to comply with local and international regulations, guidelines, and applicable directives.
    • Manage quality and adverse event complaint records for assigned therapeutic area(s) using designated safety system(s)
    • Review potential complaint data received via safety system(s), phone, fax, mail, or other methods
    • Create/complete complaint records according to established guidelines
    • Perform/coordinate follow-up to obtain missing and additional information and/or samples
    • Document additional information upon receipt (i.e. correspondence, medical records, service requests etc.)
    • Review investigation findings when complete
    • Review and close files according to established guidelines to meet required timelines
    • Provide support for: internal and external audit activities, preparation of aggregate reports, responding to follow-up questions from regulatory agencies.
    • Maintain a working knowledge of: company policies and procedures, departmental processes, and associated work instructions, evolving local and international regulations, guidelines and applicable directives , products for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials), eye anatomy, common diseases, ophthalmic evaluation procedures, eye terminology and abbreviations, safety databases(s) and reporting tools
    • Inform management of potential safety issues, emerging trends and/or concerns

    Duration & Type: 6 months Contract with a major Pharma client

    Location: Fort Worth, Texas

    Required:

    • Bachelor’s Degree (healthcare or science discipline preferred) or applicable healthcare education/certifications (i.e. RN, LVN, COMT, COT, COA, CCOA), or a combination of preferred skills & experience

    For consideration, please send resume to career@infoquestgroup.com


    + Sample Management Associate

    Duration & Type: 12 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Cambridge, Massachusetts

    Responsibilities:

    • Primary responsibility for the daily manual weighing of compounds, automated solubilization of those compounds, and distribution and shipping of products. Includes the storage, retrieval, replication and distribution of Company’sproprietary compounds to the research organization.
    • Responsible for ensuring all service level agreements are achieved on a daily basis and to work with scientific staff directly to complete orders.

    Required:

    • A Bachelor’s degree in a scientific discipline required.
    • Experience working with automation with an emphasis on compound inventory management and distribution utilizing automated systems is a plus.
    • Good personal and communication skills.
    • Ability to work well within a team.
    • The individual must understand customer focus and be professional within workplace.
    • Required Skills: Replication, Inventory, Service Level Agreements, Shipping

    For consideration, please send resume to career@infoquestgroup.com


    + Medical Device Complaint Handling Specialist

    Duration & Type: 6 months Contract with a major phrmaceutical client

    Location: Fort Worth, Texas

    Description:
    Responsible for day-to-day case management of quality technical and adverse event complaint records, including intake, follow up, triage and system entry, involving company’s medical device products. Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.

    Responsibilities:

    • Receive initial complaint from any source (ECPs, patients, internal personnel) and assure all information/data is accurately captured at point of contact.
    • Maintain an understanding of information/data required to be collected for technical and AE complaints to assure compliance with regulations and directives.
    • Manage technical and adverse event complaint records for assigned area(s) using designated safety system(s)
    • Review potential complaint data received via safety system(s) and other methods as required
    • Is cognizant of, and works efficiently within applicable timezones
    • Perform intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives.
    • Perform data entry for affiliates without access to safety database(s).
    • Triage call from all sources for quality technical complaint, Adverse Event,
      request for refund, request for replacement product and request for credit.

    • Review data entry and follow-up activities for completeness and timeliness
    • Close files according to established guidelines to meet required timelines
    • Maintain a working knowledge of:
      • company policies and procedures, departmental processes, and associated work instructions
      • evolving local and international regulations, guidelines and applicable directives for assigned therapeutic area(s) and corresponding documentation (Product Inserts, DFUs, Manuals, Promotional Materials)
      • eye anatomy, common diseases, ophthalmic procedures
      • eye terminology and abbreviations
      • safety databases(s) and reporting tools
    • Inform management of potential safety issues, emerging trends and/or concerns

    Required:

    • Education: BSN-RN – Opthamological Experience Preferred.
    • 3-5 years clinical experience in a medical device setting – ophthalmology and O.R preferred
    • 1-3 years relevant work experience (i.e. device/drug safety, compliance, quality assurance, regulatory affairs)
    • Excellent time management and prioritization skills
    • Ability to work effectively within strict timelines
    • Task and detail-oriented
    • Ability to work in a global cultural environment
    • Computer proficiency (data entry, retrieval and analy-sis)
    • Excellent written and verbal communication skills
    • Sensitive to confidentiality of data
    • Strong interpersonal, communication, and problem solving skills
    • Self-starter/ Ability to work under pressure with tight timelines
    • Culturally aware/ Experienced working with cross functional teams

    For consideration, please send resume to career@infoquestgroup.com


    + Sr. Drug Supply Manager

    Duration & Type: 6 months Contract with with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Responsibilities:

    • Plan, establishe, manage, monitor and perform activities related to preparation and distribution of supplies for US local Phase 4c studies, working with clinical team and approved vendors, in compliance with Company’s internal procedures and GxP requirements.
    • Lead the planning, creation, distribution and maintenance of clinical supplies for US Phase 4c studies (and local IITs).
    • Coordinate randomization, packaging, labeling and distribution of clinical supplies with clinical team and approved vendors as per the approved study design.
    • Be accountable for creating eCPRs with good quality, ensures that key study milestones are met.
    • Establishe the packaging design based on protocol
    • Manage all packaging activities including Work Order creation, review and approval of contractor packaging records and monitoring work at contractors
    • Responsible for materials and inventory management of supplies for US local Oncology studies.
    • Timely communicate and update clinical supply plan on study level to SCMs, ensure seamless coordination on demand/supply plan.
    • Authorize destruction of outdated material
    • Manage all finance activities with clinical team including Request for proposal for bidding and vendor selection, purchase orders and invoice approval
    • Support internal/external inspections and audits.
    • Create, review and update the demand plans based on strategic elements/study forecasts.
    • Contribute to specifications with support for IVRS set up
    • Support clinical team with medication management for IVRS studies
    • Review clinical trial protocol and provide input to drug sections.
    • Develop packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility, and overage.
    • Trigger label design process, lead packaging design and optimization, coordinate the randomization and distribution of clinical supplies according to study design.
    • Coache other team members on specific topics (e.g. packaging design, finance etc.)
    • Establish contact network with Company’s approved contractors and vendors
    • Primary liaison with contractors for external packaging and distribution campaigns
    • Establishe and manage supply related timelines with other groups as DSM, QA, and PHAD, to ensure agreed timelines are met

    Required:

    • Excellent communication skills
    • Must have Clinical Supplies Packaging experience, distribution experience, supply chain and project anagement experience
    • Bachelors degree (miniumum)

    For consideration, please send resume to career@infoquestgroup.com




    + Accounting Manager


    Duration & Type: 6 months Contract with a clinical research organization that provides support services to biotechnology and pharmaceutical firms

    Location: Carlsbad, California

    Responsibilities:

    • Support the month end close process
    • Reconciliation and analysis of general ledger accounts to include:
    • Preparation of monthly journal entries, balance sheet reconciliations, accruals, reserves, intercompany transactions
    • Processing and reviewing intercompany charges to ensure proper accounting treatment is complete at month end
    • Assist with the monthly preparation of accurate financial reports and supporting schedules
    • Support implementation of SAP system
    • Strong understanding of processes and systems with the ability to identify opportunities for process efficiency and improvement
    • Provide support related to internal controls and SOX 404 compliance activities
    • Responsible for the accuracy and timeliness of the accounts payable function including review monthly balance sheet and sub-ledger reconciliation
    • Manage the monthly accrual process
    • Manage and maintain records of all fixed asset purchases including review monthly balance sheet and sub-ledger reconciliation and audit of fixed assets
    • Other special projects, as required

    Required:

    • Solid analytical and organizational skills, accuracy and attention to detail
    • 5+ years of accounting experience
    • Proficient in MS Office applications such as Word and Excel
    • Experience with Great Plains, Concur and ReQlogic, or comparable systems, preferred
    • Ability to provide clear, concise and appropriate documentation of work performed, issues and observations

    For consideration, please send resume to career@infoquestgroup.com



    + Accounting Associate


    Duration & Type: 6 months Contract with a clinical research organization that provides support services to biotechnology and pharmaceutical firms

    Location: Carlsbad, California

    Responsibilities:

    • Assists with the management, processing and posting of timesheets
    • Investigates and corrects payroll discrepancies and errors
    • Checks time reports for missed punches and meal premiums and ensures all corrections have been made
    • Performs payroll tasks and responsibilities including verification and reconciliation of reports
    • Performs monthly vacation and sick time reporting
    • Prepares the payroll and month-end accrual journal entries
    • Assists with monthly reconciliation of accounts
    • Assists with preparation of weekly check run including printing, mailing and filing.
    • Assists with timely processing of payments and resolution of discrepancies with vendors
    • Prepares various journal entries and assists month-end close
    • Processes 1099 forms at year end.
    • Performs a wide variety of clerical and related tasks
    • Prepares information for internal and external audits as needed
    • Other special projects, as required

    Required:

    • 2-3 years general accounting experience
    • Must be detail-oriented
    • Possess excellent organization and communication skills
    • Proficient in MS Office applications such as Word and Excel
    • Experience with Great Plains, Concur and ReQlogic, or comparable systems, preferred
    • Payroll experience required

    For consideration, please send resume to career@infoquestgroup.com



    + Financial Business Analyst

    Duration & Type: 12 months Contract with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Description:

    Financial Business Analyst will be involved in the financial management of customer interactions related vendor task orders, including tracking, receiving, reconciling, forecasting and troubleshooting activities.

    Responsibities:

    • Management and tracking of all CIC vendor task orders
    • Liaison with internal team members, 3rd party vendors, Finance and brand/key stakeholders for the execution of Task Orders and creation of Purchase Orders (POs)
    • Perform goods receipts on POs
    • Proactively re-forecast and initiate Task order amendments, when required
    • Manage escalations and troubleshoots issues with Req2Pay and vendors to ensure timely payment
    • Ad hoc reporting of task order actuals and forecasts

    Required:

    • Detail-oriented with exceptional tracking and follow-up capabilities
    • Experience with SAP SRM, Sharepoint
    • Experience in managing task order administration with Finance background
    • Effective at collaboration and communication with internal and external stakeholders
    • Proven proficiency in the area of team work
    • Strong analytical and excellent organizational and communication (written & verbal) skills
    • 4 + years of relevant business experience

    For consideration, please send resume to career@infoquestgroup.com


    + Customer Operations Analyst

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Princeton, New Jersey

    Description:

    Customer Operations Analyst will manage the provide product/sales order management process; provide dedicated business analytics, and possess strong leadership skills to ensure highest customer service to the top-rated accounts of the company. The role will work closely with Sales Commercial Operations and Distribution, as well as many cross-functional teams. Customer Operations Analyst will possess proactive communication, problem-solving, and collaboration skills to ensure top customer satisfaction.

    Responsibities:

    Customer Operations Analyst will be a highly experienced professional with strong communication, operational, analytical and relationship-building skills with focus on leadership to ensure customer satisfaction in delivering on the following:

    Account Management

    • Manage the new customer application and onboarding process in collaboration with Sales, Pricing, Finance, and Contracts teams
    • Strong collaboration with Sales (to ensure strong relationship and customer satisfaction) and Supply Planning (to ensure clear customer messaging of supply constraints / availability)
    • Actively participate in Key Account Management Team and internal Customer Team meetings

    Customer Service calls with customer

    • Ensure weekly backorder report is communicated within agreed-to timelines
    • Oversee One-time buy requests in Salesforce.com and understand potential opportunities
    • Ensure product substitution due supply constraints (when applicable)

    Sales Order Management

    • Process and maintain customer sales orders
    • Ensure management of EDI and Manual sales orders in SAP
    • Provide clear communication to Sales Logistics and Distribution related to order changes

    Open Order reporting and tracking

    • Manage dating changes based on customer requirements
    • Understand Order Release process and provide customer insight
    • Handle and approve customer expedite requests based on agreed-to guidelines
    • Manage shortages, destructions, and damages reporting to Distribution
    • Issue call tags (when applicable)

    Proactive Customer Analytics

    • Customer account analytics and product availability reporting
    • Proactively work with customers to improve forecast accuracy with analytical data
    • Partner with Sales Commercial Operations team to understand Customer Scorecard metrics
    • On Time in Full (OTIF) reporting and root cause analysis

    On-going Customer Operations Functions

    • Use of SAP/BI reporting, Qlik Sense, and Siebel to analyze customer data
    • Ensure Customer Operations SOPs and work instructions are current
    • Comply with SOX protocols
    • Use of Customer Connect and provide shipment information to customers (when applicable)

    Continuous Process Improvement

    • Support SAP enhancements and provide insight to on-going system improvements
    • Identify areas for process improvement across all of Customer Operations
    • Ensure collaboration within cross-functional teams and highlight areas of improvement
    • Experiment and deliver solutions thru Innovation

    Required:

    • Bachelor’s degree required, advanced degree preferred
    • 4 + years of relevant business experience
    • SAP experience required
    • Strong MS Excel and Power Point skills
    • Understanding of the generics pharma industry preferred
    • Excellent organizational and communication (written & verbal) skills
    • Ability to create and maintain customer relationships
    • Strong leadership and active listening skills
    • Strong analytical skills
    • Detail oriented, able to multitask and meet deadlines
    • Delivers timely/sound decisions to the business with complete information
    • Self-starter and results driven – always goes the extra mile
    • Proactive and collaborative

    For consideration, please send resume to career@infoquestgroup.com


    + Training Specialist

    Duration & Type: 3 months Contract with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Responsibities:

    • Support Company’s Project Excellence Lead and Project Managers to create a sustainable web training on company’s project methodology
    • Organize and develop web training modules using Articulate
    • Create storyboards outlining the project management process
    • Develop alternative training methods if expected improvements are not seen

    Required:

    • Must have 3-4 years prior experience creating training curriculums and web training modules
    • Must have advanced capabilities using Articulate software
    • Must have intermediate knowledge of managing a SharePoint site
    • Must be skilled in getting information from identified stakeholder around training requirements – observing and receiving
    • Must have excellent communication and time management skills
    • Must possess ability to work independently
    • Experience with ARTICULATE, Microsoft Sharepoint
    • Minimum Degree Required: Associate’s Degree

    For consideration, please send resume to career@infoquestgroup.com


    + Financial Analyst

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: East Hanover, New Jersey

    Description:

      The position holder will be responsible to ensure that all financial transaction processes and analytical requirements for the Business Franchise are completed efficiently and accurately, with appropriate supporting documentation, back-up, commentary, etc. The position holder will also support the Finance Director for the Franchise in all the financial matters and help identify opportunities for financial process improvements.

    Responsibities:

    Business Planning / Reporting:

    • Develop a core understanding of the Franchise Spend including Advertising & Promotion spend, as well as a thorough understanding of all Franchise activities and their impact on costs.
    • Partner with Franchise teams to develop robust and realistic spending forecasts including monthly rolling forecast, spot landings, latest estimates and annual budget. Understand key business drivers.
    • Prepare and analyze Franchise spending variances to forecasts, including explanations, as well as recommendations for follow-ups.
    • Coordinate with POR team in India for PO creation and Change orders and help provide Finance approval on the POs.
    • Manage monthly or quarterly vendor reconciliation, including timely cleanup of GRIR/IRGR issues.
    • Prepare and coordinate posting of monthly accruals and other standard journal entries in accordance with GAAP and company policies.
    • Suggest and initiate process improvements and corrective actions, where appropriate.
    • Address requests for more detailed analysis, data, reports, etc, and coordinate with other functional areas as required.
    • Compliance with Federal Sunshine Reporting Requirements as it pertains to Franchise operations.
    • Identify and introduce new/ improved analyses which provide insights to different areas of the business and aids decision making.

    Business Partnering/ Leadership:

    • The individual will be expected to establish himself/herself as a key contributor to Business Partners and drive key processes within the area he/she will be supporting – this will require cross-functional coordination efforts, the ability to work with various levels of management, with strong communication and negotiation/influencing skills.
    • Act as a financial resource to support Finance Director of the Franchise, Franchise Head, other leadership team members of the Franchise.
    • Work with US FSC, including Req to Pay and other Oncology finance teams to fulfill financial responsibilities for the Franchise.
    • Participate/initiate projects/analyses on an as needed basis.
    • Actively partner with Franchise teams to ensure process adherence, report improvement and communication, and policy compliance.
    • Provide excellent customer service and develop and maintain successful cross-functional working relationships based on mutual trust, responsiveness, and reciprocity and consistently strive to live up to finance and business partners’ expectations.
    • Proactively develop and deliver analyses and reports to support business decisions using all available data sources.

    Required:

    • Minimum 2 years of directly and progressively responsible experience and demonstrated achievement in financial analysis, preferably in the pharmaceutical industry.
    • Broad understanding of various financial management areas such as financial statement analysis, accounting, budgeting, profitability analysis, costing, consolidated financials.
    • Financial Accounting Skills: Budgeting, Planning, Financial Analysis, Financial Reporting, Preparing presentations
    • IT Skills: Good knowledge of Excel, Working knowledge of Power Point, Word and other Microsoft Office tools, SAP R3, BW, Cognos / TM1 (desirable – not a must)

    For consideration, please send resume to career@infoquestgroup.com



    + Project Engineer

    Description: Key team member executing projects in clean utilities, equipment, automation, process improvements, as well as design, installation, start-up, commissioning, and qualification of new investments.

    Key responsibilities:

    • Provide project management leadership to ensure key initiatives are well understood and effectively deployed
    • Maintain project budgets while negotiating services and equipment proposals with vendors
    • Understand end user requirements and convert requirements into functional and efficient designs
    • Perform basic engineering calculations
    • Coordinate installation and construction contractors on day-to-day progress activities
    • Communicate and collaborate with other team members and departments
    • Provide qualification and validation assistance when necessary
    • Benchmark with other company sites to establish best-practices
    • 25% travel domestic travel

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Emeryville, California

    Required:

    • BS in Chemical or Mechanical Engineering
    • Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests and site acceptance
    • Direct experience with regulated environments (i.e. cGMP, WHO, etc.)
    • Strong technical expertise in biotech unit operations and equipment, especially microbial fermentation and purification
    • Experience in managing contractors in a construction and commissioning environment.
    • Design and Installation experience in process and industrial utility systems including HVAC, Plant Steam, purified water, compressed air and waste treatment
    • Strong spoken and written English
    • Some knowledge of Spanish is a plus
    • 5 years industry experience, 1+ year experience in pharmaceutical/biotech/vaccine operations with thorough working knowledge of production unit operations and validation principles

    For consideration, please send resume to career@infoquestgroup.com


    + Reverse Logistics Analyst

    Description: This associate will be involved in data analysis and reporting, processing of customer returns through our in house SAP pricing tool and interacting with wide range of internal and external business partners (vendors, customer).

    Duration & Type: 12 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Princeton, New Jersey

    Key responsibilities include:

    • Provide routine reporting and develop new reports to enable communication and support metrics development
    • Performing review of customer returns and process through our in-house SAP pricing tool
    • Coordinating with returns processor, IT, and key business owners (e.g. Product Master and Pricing Teams) to ensure product and pricing information to process returns is current and accurate
    • Collaborating with Financial Service Center team to perform reconciliation analysis of customer debits compared to issued credits as well as day to day troubleshooting
    • Performing ad-hoc analytics to investigate product returns discrepancies or data needs
    • Performing trend analytics to reveal root causes and lower Sandoz’s risk and cost of product returns

    Required:

    • Strong working knowledge of SAP
    • 1-3 year(s) of experience in SAP (Sales and Distribution, AR/AP, Materials Management modules)
    • Knowledge of order to cash processes
    • Knowledge of Pharmaceutical returns a plus
    • Strong understanding of the accounts receivable process
    • Strong interpersonal and communications skills
    • Ability to prioritize tasks with a self-starter attitude
    • Strong attention to detail and ability to summarize and communicate at all levels of the organization
    • Ability to research, analyze and interpret data and make recommendation to management
    • Team player (displays enthusiasm, confidence & commitment)

    For consideration, please send resume to career@infoquestgroup.com


    + Data Control Analyst I

    Description:

    This associate will handle the entry and maintenance of large amounts of master data within the SAP environment. Additionally, responsible for implementing and adhering to strong compliance controls regarding master data, providing high level analysis and reporting for long term or recurring projects.

    Duration & Type: 12 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Sumit, New Jersey

    Major Accountabilities:

    • Serve as backup to the Senior Data Control Analyst regarding creation or maintenance of new master data records in the CP1 Pricing Master system.
    • Create or maintain new master data records in the CP1 Customer Master system.
    • Provide valid backup for selected entries on a weekly customer master audit report.
    • Perform year-round proactive maintenance of customer accounts, closing out inactive accounts, and updating customer state pharmacy license data.
    • Update EDI EDPAR table data, syncing Seqirus account numbers with customer internal account numbers.
    • Maintain document output records, determining what records are EDI, printed, or not printed for all customer accounts.
    • Assist Customer Service Manager with creating new processes and procedures for the Data Control department, ensuring that set procedures are followed by all members of the team.
    • Serve as a go-between for Customer Service and Commercial Finance for customer returns, tracking the progress of both departments and documenting the status of returns for all customers.
    • Serve as a go-between for Customer Service and Contracts and Pricing, detailing the expected pricing and contractual obligations for our customers.
    • Facilitate a weekly returns reconciliation meeting with the heads of Operations, Sales and Commercial Finance.
    • Design and implement long term reporting needs for internal and external partners. Determine if reports can be delegated upon creation or if they must remain within data control.
    • Assist in the design and maintenance of recurring forms utilized by the Customer Service team. Includes order form, credit limit/credit memo request forms and returns credit forms.
    • Compiles Customer Response Unit call log data on a weekly basis and provides back to the team, as well as creating detailed reports of month by month analysis and three-year review.
    • Assists Customer Response with Adverse Event reconciliation reporting, as part of a weekly cross check with the Med Communications team.

    Required:

    • 3-5 relevant experience in the pharmaceutical customer service industry.
    • High level of experience with Microsoft Excel and/or SAP 6.0 or later.
    • Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
    • Able to effectively document new procedures to be added to training materials.
    • Must have excellent communication skills and strict attention to detail.
    • Able to admit to mistakes or oversights and work in conjunction with internal partners to resolve the problems.
    • Ability to work with cross-functional teams (Finance, Sales and Distribution, QA, IT and senior managers).
    • Bachelor’s Degree required at minimum.

    For consideration, please send resume to career@infoquestgroup.com


    + Medical Writer

    Description:

    The Medical Writer is responsible for researching, writing, editing and collaborating with internal teams to complete clinical study protocols, package inserts and clinical study reports for FDA Biologics License Application (BLA) submission.

    Duration & Type: 4 months Contract with our client – a global leader in the pharmaceutical industry

    Location: San Diego, California

    Responsibilities:

    • Assure completion of high quality clinical study reports for FDA Biologics License Application (BLA) submission.
    • Manages, researches, and writes clinical study protocol, package insert and report writing. Coordinates report and protocol writing activities.
    • Schedule and coordinate cross functional reviews of clinical study reports; gain cross-functional consensus. Tracks comments and obtain final approval per SOP.
    • Oversee, design, write and critically edit clinical study section of package inserts.
    • Create and establish department SOPs. Generate and improve processes and procedures.

    Required:

    • Minimum of three years of experience in medical writing
    • Advanced knowledge of clinical research.
    • Ability to author clinical protocols and/or study reports.
    • Ability to manage, oversee and work on multiple projects simultaneously.
    • Strong science/clinical trials background.
    • Comprehensive understanding of AMA guidelines
    • Flexibility in meeting the changing demands of each project
    • Bachelor’s degree in a medical or medically-related field and/or equivalent experience

    For consideration, please send resume to career@infoquestgroup.com


    + Assistant Editor

    Description:

    The Assistant Editor supports Diagnostics Global Marketing by managing & coordinating GRP process which is responsible for ensuring that Grifols promotional & educational materials produced/distributed by Grifols are compliant with stringent country, state & company regulations, and policies.

    • Providing expertise with editorial material reviews & assisting with the creation of marketing copy.
    • Demonstrates initiative by implementing consistent standards of GRP review, spelling & grammatical accuracy of content, validation of references & trademarks & resolution of editorial issues.
    • Maintains documentation & archives GRP review decisions.
    • Assists in the development of creative copy that is consistent & effective for marketing materials, messaging, words & audio that accompany promotional visuals.
    • Additional activities may include production management of promotional materials, operational support activities & other duties as assigned.
    • Reviews require compliance with product/company brand guidelines, messaging requirements & editorial standards; the accuracy of spelling & grammar, verified reference quotations, content clarity & organization.
    • Facilitates GRP reviews, accurately documenting revisions required by members.
    • Receives submissions from initiators, reviews for completeness, distributes to appropriate GRP reviewers &ensures that reviews are completed/returned in a timely manner
    • Resolves any editorial content issues remaining after GRP reviews.
    • Assists in writing/editing marketing copy & content as part of marketing communications team on a wide range of projects.

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Emeryville, California

    Required:

    • Bachelor’s degree in English, Communications or Journalism
    • 3-5 years’ of experience in biopharm, biotech, pharma or healtcare
    • Command of copy editing skills including grammar, spelling, punctuation & syntactic rules of the English language.
    • Knowledge of medical/pharmaceutical/scientific terminology/data
    • Experience in editing documentation for a highly technical audience including work with promotional materials
    • Experience with federal regulations governing pharmaceutical advertising & the American Medical Association (AMA) rules of style
    • Experience in advertising copywriting; working with product brand guidelines is a plus
    • Proficient in the use of Adobe Acrobat Professional & Microsoft Office
    • Proficient in English (fluency in Spanish is a plus)
    • Experience using ZincMap system would be a plus
    • This is a junior level position.

    For consideration, please send resume to career@infoquestgroup.com


    + Document Controller

    Description:

    The Document Controller supports the development and maintenance of quality processes related to document management for global Quality groups as well as EDGE projects on an as requested basis. This role oversees the document management process to provide assurance that all documents are suitability reviewed, implemented and approved and comply with cGMP, legal, regulatory requirements, and Seqirus Quality Manual requirements by performing document control activities using the both the legacy and incoming Enterprise Document Management Systems (EDMS).

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Holly Springs, North Carolina

    Responsibilities:

    • Perform Document Control activities within legacy and incoming EDMS, such as verification of form completion, troubleshooting workflows, and report generation.
    • Format and edit documents, including Standard Operating Procedures, Specifications, Controlled Forms, and Policies that support GMP operations and comply with cGMP and FDA guidelines, and additional quality standards addressed in Seqirus’ Quality Manual.
    • Assist investigating deviations and CAPAs related to the legacy and incoming EDMS.
    • Support the development and continuous improvement of Global Quality Systems document management system SOPs and Work Instructions for the new EDMS.
    • Ensure adherence to the Standard Operating Procedures that govern the use of the legacy EDMS.
    • Report Quality KPIs to management as requested.

    Required:

    • 2+ year’s experience as a document controller strongly preferred.
    • 2+ year’s experience in QA function or pharmaceutical manufacturing preferred.
    • Must be highly skilled in Microsoft Word, Excel and experienced in PC’s and databases.
    • Must be able to proof work and identify non-standard format or wording, and errors within documents.
    • Must have excellent communication skills and strict attention to detail.
    • Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.
    • Bachelor’s degree or equivalent work experience

    For consideration, please send resume to career@infoquestgroup.com


    + Training Coordinator

    Description:

    The training coordinator provides administrative support to ensure implementation, maintenance and monitoring of the training requirements, and the GxP Training Program.

    Duration & Type: 8 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Holly Springs, North Carolina

    Responsibilities:

    • Perform Document Control activities within legacy and incoming EDMS, such as verification of form completion, troubleshooting workflows and report generation.
    • Perform web training administrative activities; check quizzes, activate courses/sessions, create/assign activities, roles or people, maintenance of sessions, activities, create and unlock user accounts.
    • Support departments in the creation and maintenance of training plans, training matrices and training records.
    • Track training activity completion including SOPs/Courses and report training metrics on a timely basis to management.

    Required:

    • Bachelor’s degree or equivalent work experience
    • Knowledge of Good Manufacturing Practices (GMPs) required
    • Previous Training Coordinator experience required
    • 2+ years experience in QA function or pharmaceutical manufacturing preferred
    • Must be highly skilled in Microsoft Word, Excel and experience in PC’s and databases.

    For consideration, please send resume to career@infoquestgroup.com


    + Category Buyer

    Description:

    • Assist with the support of R&D, Commercial and several other areas within the organization.
    • Ensure all procurement spend is managed compliantly across assigned categories and spend.
    • Work with the Category Manager to deliver savings and improvements in KPIs across key Procurement
    • imperatives of cost, risk, quality, service, growth, innovation and governance as follows:
    • Using procurement best practice across spends categories assigned.
    • Develop and deliver of a portfolio of saving and value adding projects that will reduce the total acquisition cost of spend as measured and documented through the savings process.
    • Drive local procurement initiatives through implementation of Global Sourcing Strategies and local RFQ’s in conjunction with key business partners.
    • Attend regularly functional management meetings to present procurement updates
    • Ensure compliance to Procurement Policy and SOPs.
    • Manage master data and change controls as appropriate to support R&D and Commercial categories.
    • Ensure all procurement orders and contracts as actioned are raised compliantly
    • Manage savings and contracts lists and produce monthly report appropriately.
    • Change champion in procurement to ensure compliant change approach

    Duration & Type: 6 months Contract with our client – a global leader in the pharmaceutical industry

    Location: Cambridge, Massachusetts

    Required:

    • Bachelor’s degree
    • 1 to 3 years procurement experience.
    • Knowledge of R&D categories, including Research, Clinical Development, Medical Affairs and Regulatory. Commercial and Marketing would also be advantageous.
    • Ability to develop relationships with key customers and suppliers.
    • Able to engage with senior leaders
    • Broad knowledge of range of Categories with specific focus on key assigned categories.
    • Self – starter, resilient and results driven.
    • Excellent Word, Excel and PowerPoint skills
    • Tenacious and works with integrity and can be relied on to help achieving savings within deadlines agreed
    • Able to support other procurement areas as required.

    For consideration, please send resume to career@infoquestgroup.com


    + B2B Collections Analyst

    Description:

    This role is focused on the past due account resolution by contacting customers to secure payment or to resolve payment disputes.

    Duration & Type: 3months Contract with our client – a global leader in the pharmaceutical industry

    Location: Fort Worth, Texas

    Responsibilities:

    • Ensure all collection KPIs are met for assigned accounts in portfolio.
    • Contact customers via various communication tools to secure payment for past-due invoices.
    • Identify root cause of late payments and recommend / implement process improvements to prevent recurrence.
    • Escalate potential non-payment issues to appropriate stakeholders; follow up with all stakeholders.
    • Effectively communicate outcomes and/or next steps to appropriate stakeholders.
    • Ensures all accounting policies and procedures are adhered to, including NFCM controls.

    Required:

    • Completed High School (Diploma or GED) but Bachelor’s degree preferred
    • 1 year of portfolio collections experience
    • years of collections experience
    • Commercial Collections experience required
    • Pharmaceutical industry experience is a plus.
    • SAP experience preferred.
    • Demonstrated understanding of key business fundamentals and value drivers.
    • Outstanding oral and written communications skills.This is NOT a Call center collection environment

    For consideration, please send resume to career@infoquestgroup.com


    + Customer Service Representative

    Duration & Type: 12 months Contract with a major pharmaceutical client

    Location: Summit, New Jersey

    Description:

    Reporting to the Customer Service Manager, the Customer Service Representative will support multiple stakeholders within the US Influenza Vaccines business unit. This is a customer-facing role; direct interactions which represent company’s Vaccines customers in a positive manner will be the primary responsibility.

    Responsibilities:

    • Respond to customer inquiries, prioritize and coordinate customer requests within the Customer Service team.
    • Responsible for monitoring and creating customer data and sales orders in the ERP system.
    • Be an integral member of the Customer Service operations team and be responsible for order creation through shipping; promptly identify and troubleshoot issues and coordinate resolution across multiple functions.
    • Interface frequently with multiple levels of the organization in varied functions to understand requirements and resolve issues, including Customer Service, Distribution, Contracts and Pricing, Marketing, Sales, and AR/Finance.

    Required:

    • Hands-on experience in phone systems, order entry and Microsoft Office (Excel, PowerPoint, Outlook).
    • Must demonstrate excellent organization and communication skills (written and verbal), strong customer focus, ability to learn and operate within technically complex software systems
    • Must be comfortable working within a matrix organization balancing action items from multiple managers. Previous experience in the pharmaceutical/medical industry.

    For consideration, please send resume to career@infoquestgroup.com


    + Accounts Receivable Analyst

    Duration & Type: 6 months contract job with a pharmaceutical industry client

    Location: Summit, New Jersey

    Description:

    The position holder will process receipts from customers and proactively manage customers so that all debts are recovered within payment terms.

    Responsibities:

    • Allocate receipts from customers to the correct customer account and invoices.
    • Reconcile monthly supplier/customer statements.
    • Monitor and resolve customer deductions to ensure that they are correct and to ensure timely receipt of customer receipts as necessary.
    • Review and set customer credit limits, liaise with customer services as necessary.
    • Produce and send manual invoices to customers as required.
    • Produce information required for financial cash flow monitoring purposes.
    • Maintain master data including periodic review and liaison with procurement and customer services.
    • This position is based in Summit to provide a real-time link with customer services and commercial operations while the processes in and around new SAP instance are resolved. As such, there is likely to be a significant amount of ad hoc work support that will need to be provided.
    • Undertake cross training, as necessary and permitted under SOD, to be able to provide cover for other positions within the department
    • Critically evaluate current processes and procedures and seek to simplify where possible while maintaining adequate internal controls.

    Required:

    • 5 years previous experience of Accounts Receivable using SAP.
    • MS Office skills- in particular, Excel and Word.
    • Good communication skills.
    • Previous experience of working in a fast-paced and changing organization and dealing with multiple companies and different countries.
    • Previous experience of dealing with pharma customers based in the USA preferred.
    • Education: Bachelor’s Preferred.
    • Disciplined, methodical and rigorous.
    • Hands on with an eye for details but sees the big picture.
    • Results orientated and results driven who takes ownership.
    • Good communication skills, persuasive, pragmatic and flexible.

    For consideration, please send resume to career@infoquestgroup.com