Careers


+ Architect - Active Directory

Position Type: 12 months Contract

Location: Cambridge, Massachusetts

Position Description:

Complete oversight of entire AD architecture lifecycle:

  • 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

Position Type: 12 months Contract

Location: East Hanover, New Jersey

Position 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.

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




+ Regional Clinical Research Associate - Florida

Position Type: 12 months Contract

Location: Orlando, Florida

Position Description:

Therapeutic area is Cardiovascular, Respiratory and Ophthalmology.

  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May rep- resent 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 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

+ Regional Clinical Research Associate - Connecticut

Position Type: 12 months Contract

Location: Connecticut

Position Description:

Therapeutic area is Cardiovascular, Respiratory and Ophthalmology.

  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role. May rep- resent 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 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 re- porting, 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.).

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

+ Study Manager

Position Type: 6 months Contract

Location: Fort Worth, Texas

Position Description:

  • Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots
  • Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
  • Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
    Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage

  • Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded.
  • Participates in cross functional teams and provides guidance on best practices for clinical supplies management.
  • Leads process improvement initiatives and training efforts as a clinical supplies SME
  • Supports internal/external inspections and audits
  • Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs.

Required:

  • Proficiency in the design and use of Interactive Response Technology
  • Project management and process improvement experience
  • Minimum 5-7 years of experience managing clinical supplies or relevant experience
  • Proven leadership behaviors and strong communication skills
  • Medical Device experience a plus
  • Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
  • PMP certification is preferred
  • Bachelor’s degree required, Master’s degree is a plus

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

+ Expert Clinical Manager

Position Type: 6 months Contract

Location: East Hanover, New Jersey

Position 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.

  • 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 Novartis 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

+ Clinical Research Analyst

Position 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.

Education: 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.

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

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

+ Patient Safety Scientist

Position Type: 6+ months Contract

Location: Broomfield, Colorado

Position Description:

  • Support management of Patient Safety operational processes at Country Organization in ensuring compliance with global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of marketed and investigational products (drugs and devices).
  • Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
  • Manage reporting/submission/distribution of safety reports/updates/information (e.g.SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments, if applicable.
  • Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
  • Interact and exchange relevant safety information with Patient Safety associates, other functional groups and third party contractor, if applicable.
  • Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
  • Management and maintenance of all relevant Patient Safety databases.
  • Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to local health authority, development and implementation of corrective action(s) as needed.
  • Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.
  • Ensure support for and close-out of audits, corrective action plan, and investigation and Health Authority inspections.
  • Ensure training, mentoring and oversight of staff as applicable.
  • Manage and maintain efficient Patient Safety filing and archive system.

Required Skills:
Pharmacovigilance, Healthcare/Medical

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

+ Clinical Research Associate

Position Type: 6+ months Contract

Location: Emeryville, California

Position Description:

  • Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs & study protocols.
  • Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines & metrics are met & maintained throughout the study.
  • Follow Good Clinical Practice (GCP)
  • Tracks study specific tasks & progress of the trial.
  • Performs regulatory document review & approval for IP release.
  • Assists in the coordination & planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
  • Conducts monitor training.
  • Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, & closeout visits, in conformance to all relevant laws, regulations, guidelines & internal SOPs/policies.
  • Understands & implements processes for distribution & tracking of UADE’s, as applicable.
  • Collaborates with data management to resolve queries.
  • Facilitates investigator site payments, as applicable.
  • Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
  • Assists in evaluation of vendor performance during conduct of the study.

Required:

  • Bachelor’s degree in a life science field.
  • Prefer 8 years of experience in clinical research, including a minimum of 3 years field monitoring and 4 years in lead CRA role.

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

+ Formulations Scientist

Position Type: 12+ months Contract

Location: Fort Worth, Texas

Position 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.

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

Position Type: 18 months Contract

Location: Cambridge, Massachusetts

Position 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.

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

Position Type: 6 months Contract

Location: Fort Worth, Texas

Position Description:

  • Responsible for day-to-day case management of quality and adverse event complaint records involving Novartis manufactured products.
  • Complaint handling accountability reflect 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…..)
  • 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

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

+ Clinical Research Associate

Position Type: 4 months Contract

Location: San Diego, California

Position Description:

  • Assists in the development of study timelines and ensures compliance.
  • Assists in the management of vendors.
  • Prepares key reports and documents on progress of study for study manager.
  • Monitors adherence to the regulatory document collection process.
  • Interacts with data management, safety, regulatory personnel, and other functional groups.
  • Assists team members in reviewing data listings and writing queries.
  • Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance.
  • Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs.
  • Participates in CRF development and completion

Required:

  • Bachelor’s degree in a life science field is required.
  • Requires 2-3 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
  • Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
  • Good knowledge of therapeutic area assigned.
  • Strong knowledge of ICH/GCP Guidelines and EDC process.
  • Strong verbal and written communication skills.
  • Ability to present at internal study team meeting(s).
  • Ability and willingness to travel.

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

+ Process Development Sr. Scientist II - (Upstream)

Position Type: 4 months Contract-to-Hire

Location: Emeryville, California

Position Description:

  • Provide technical or scientific expertise and leadership in the upstream process development of mammalian cell culture derived recombinant proteins and monoclonal antibodies.
  • Responsible for developing cell culture medium, feeding strategies, process parameter optimization, and scale-up to support large scale production of material for preclinical and clinical activities.
  • Proficient in writing development reports, protocols, batch records and technology transfer reports.
  • Applies scientific and engineering expertise to develop recombinant protein production processes suitable for large-scale cGMP manufacturing.
  • Responsible for independently identifying actions required to support departmental objectives.
  • Execute action plans independently, as part of a team, or as the lead for a departmental team.
  • Responsible for representing the functional area or capable of leading a cross-functional team to achieve identified objectives.
  • Independently prepare and critically edit procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND, BLA, or equivalent regulatory submission.
  • Develop creative, novel programs to meet departmental objectives.
  • Lead others in problem-solving efforts. Mentor/train staff in relevant principles and/or guidelines. Responsible for serving as technical consultant within functional area or site.
  • Independently design, execute, and interpret results for novel and scientifically complex study programs.
  • Responsible for directing others in study execution.
  • Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.

    NOTE: FOR THE RIGHT CANDIDATE THIS POSITION COULD CONVERT IMMEDIATELY!

Required:

  • Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology) – PhD with 5 years or MS with 8+ years, or BS with 10-11 years of experience
  • MUST have industry experience working with mammalian cells in upstream process development.
  • Prior GMP experience is REQUIRED
  • Must demonstrate strong scientific/technical and interpersonal skills & the ability to communicate effectively.
  • A good working knowledge of quality design approaches and process analytical tools to drive process understanding and develop robust processes is highly desirable.
  • Capable of leading a cross-functional team to achieve identified objectives.
  • Ability to independently prepare & critically edit complex procedures or technical reports.
  • Must have excellent problem solving skills.

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



+ Medical Writer

Position Type: 4 months Contract

Location: San Diego, California

Position 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.

  • 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

Position Type: 6 months Contract

Location: Emeryville, California

Position 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, sate & 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; 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.

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

Position Type: 6 months Contract

Location: Holly Springs, North Carolina

Position 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).

  • 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 supportGMPoperations 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

Position Type: 8 months Contract

Location: Holly Springs, North Carolina

Position Description:

    The training coordinator provides administrative support to ensure implementation, maintenance and monitoring of the training requirements, and the GxP Training Program.
  • Perform Document Control activities within legacy and incoming EDMS, such as verification of form completion, troubleshooting workflows and report generation.

  • Perform webTraining 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

Position Type: 6 months Contract

Location: Cambridge, Massachusetts

Position Description:

  • Assist in the support of R&D, Commercial and several other areas within 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

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

Position Type: 3 months Contract

Location: Fort Worth, Texas

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

  • 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 experinece
  • 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 environmnet

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