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regulatory affairs in Boston

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    1. Program Manager - GEMS

      Program Manager, Genetically Engineered Models & Services (GEMS) Boston, MA areaBASIC SUMMARY:Responsible for coordinating complex programs and provide consultation on business and scientific issues across the GEMS organization. Provide independent program management and serve as genetic testing subject matter expert. Serve as a single point of contact as a scientific liaison between the BBO ...

    2. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    3. Director - Clinical Affairs - Companion Diagnostics - Cambridge, MA

      Fast growing biotech company working on highly specialized products in the oncology field seeking individual with ability to directly oversee clinical trial programs for companion diagnostic products. Activities: *** Develop clinical trial plans for predictive, prognostic and diagnostic tests incorporating requirements from doctors, regulatory agencies and payor groups. *** Execute ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    4. Program – Clinical Trial Coordinator

        The Program Clinical Trial Coordinator (P-CTC) provides daily, direct support to the Director of Global Clinical Operations and Clinical Development Team Lead to drive efficiency and consistency across programs.  He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the P-CTC represents inVentiv Health ...

    5. Product Safety Review Consultant - Pharmacovigilance

        Cambridge, MA Product Safety Review Consultant Contract - BHCJP00013769/BHCJP00013739 W-2 ONLY  DESCRIPTION This role is responsible for aggregate review and reporting of safety data from various sources in support of regulatory aggregate reporting requirements, as well as safety surveillance and risk management activities pertaining to products. RESPONSIBILITIES Summarize safety ...

    6. Associate Medical Director

      A Drug Safety Associate (DSA), known also in the industry as a Pharmacovigilance Officer, is a health science professional responsible for the monitoring, data collection and analysis, and reporting of drug safety information for compliance with drug safety regulations in the U.S. and international markets.   Cambridge, MA Associate Medical Director Contract - BHCJP00013871 W-2 ONLY ...

    7. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    8. Program Manager - GEMS

      Program Manager, Genetically Engineered Models & Services (GEMS) Boston, MA area BASIC SUMMARY: Responsible for coordinating complex programs and provide consultation on business and scientific issues across the GEMS organization. Provide independent program management and serve as genetic testing subject matter expert. Serve as a single point of contact as a scientific liaison between the ...

    9. Global Medical Director-Biopharm with Multi-Billion Dollar Investment

        Global Medical Director Needed for US Biopharmaceutical Company with Recent Multi-Billion Dollar Investment Global Medical Affairs Strategy Clinical Development Phase III & IV Trial Management Oncology Immunology Neurology   Executive Director Level | Regulatory Affairs | Cross-Therapeutic Location: Boston Salary: $275,000 - $350,000 + bonus + excellent benefits + ...

    10. Scientist - Greater Boston

      Job Description: The ideal candidate for the Scientist role will be responsible for the development, optimization and qualification of robust invitro bioassays in house suitable for the characterization of biological potency of therapeutic biologics or small molecule drug candidates. She/he will serve as tech lead and SME to transfer the optimized bioassays to CROs for further phase ...

    11. Consumer Marketing (Associate/Director)

        Top globally recognized pharmaceutical company Location: Near Somerville, MA (Cambridge, MA) Compensation: $100 - $140K Position Background: The incumbent will develop and execute innovative strategies related to marketing and awareness. Must be able to create a best-in-class experience for all stakeholders, most importantly for people living with MS. Roles & Responsibilities: ...

    12. CMC Project Manager

      An expanding pharmaceutical company in Lexington, MA has an immediate need for a CMC Regulatory Affairs Project Manager.DESCRIPTION: Knowledge of global CMC regulatory submission requirements: including submission formats eCTD for IND, IMPD, NDA, MAAs and NEES. Department lead on the clinical and commercial CMC submission processes. Tracking global submission activities. Oversees regulatory ...

    13. QUALITY ASSURANCE - ASSISTANT DIRECTOR - COMBINATION PRODUCTS

      (Need 2 of these people) QUALITY ASSURANCE - ASSISTANT DIRECTOR, COMBINATION PRODUCT Chicago, Il FULL RELO DESCRIPTION The R&D GMP Quality, Clinical Product Supplies, organization is responsible for Product Quality Assurance for investigational medicinal products (IMP), including both pharmaceutical drug and drug/device combination products. These activities comprise of disposition ...

    14. Director of CMC Regulatory Affairs

        Job Title: Director of CMC Regulatory Affairs             Leading pharmaceutical development company   Location: Boston, MA   Description: Provide regulatory direction and strategic technical input across all regulatory programs.   Responsibilities: Screen development of new requirements and inform senior management of impact to the company Give direction for regulatory ...

    15. Clinical Trial Coordinator

          Purpose of Job:   The Program Clinical Trial Coordinator (P-CTC) provides daily, direct support to the Director of Global Clinical Operations and Clinical Development Team Lead to drive efficiency and consistency across programs.  He or she has the responsibility to support the project team to achieve quality results in a cost-effective timely manner. In doing this, the P-CTC ...

    16. Program Manager - GEMS

      Program Manager, Genetically Engineered Models & Services (GEMS) Boston, MA area BASIC SUMMARY:  Responsible for coordinating complex programs and provide consultation on business and scientific issues across the GEMS organization. Provide independent program management and serve as genetic testing subject matter expert. Serve as a single point of contact as a scientific liaison between the ...

    17. US Medical Director - Post Launch Support - Autoimmune Therapeutics

      Global pharmaceutical leader seeking an experienced Medical Director to provide key support of newly launched drugs and mature drugs during Phase IV postmarket surveillance activities. Key Areas of Responsibility: *** Meet with KOLs and determine market acceptance of product from physicians, providers, payors and patient representatives. *** Own activities involved in reporting of ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    18. Medical Director- Oncology Clinical Development

      Medical Director- Oncology Dept: Clinical Research & Development Location: Boston area (will relocate within the US) Job Description Summary: Our client is a growing biotech company exploring targeted therapies for cancer. The Company seeks a Medical Director – Oncology who is highly motivated and who desires an opportunity to make key contributions to the medical research department. ...

    19. Quality Assurance Professional

          Hello,   My name is Nathan and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Quality Assurance Professional for a prominent client of ours.  This position is located in Lexington, MA. Details for the position are as follows:   Job Description: Seeking a Quality Assurance Professional to work in the US External QA team. This unit ...

    20. Senior Data Management Project Manager

        Description   The Sr. Data Management Project Manager is responsible for developing and implementing project plans for outsourced studies, ensuring that the activities are completed by vendors according to specified quality standards and timelines, and for coordinating ongoing data management activities with vendors to support the flawless execution of a clinical trial, by acting as the ...

    21. Regulatory Affairs Specialist

        Hello,   My name is Alexis and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Specialist for a  prominent client of ours. This position is located in Emeryville, CA. Details for the position are as follows:   Job Description: Seeking a Regulatory Affairs Specialist. Candidate must speak fluent Spanish, Mandarin, or ...

    22. QA  Regulatory Affairs Specialist

      QA / Regulatory Affairs Specialist This Position pays Market + Full Benefits Description Job Summary: This QA/RA Specialist is responsible for maintaining and ensuring that the company quality system meets FDA requirements for class I medical devices (IVD and ASR). The QA/RA Specialist is also responsible for ensuring that products and their labeling meet all regulatory requirements ...

    23. Change Management and Communications Lead

      Streffco Consultants, Inc., is an international staffing and systems integration organization. We provide technology and business operations resources on a project, contract, contract-to-hire or direct hire basis.   Title: Change Management and Communications Lead Job ID: 6823 Industry: Biotech/Pharmaceutical Location: Cambridge, MA Duration: 6 Month Contract Pay Rate Range: Depends on ...

    24. Medical Writer I

       Our client is looking for Medical Writer I in Raynham, MA, USA.   Job Title - Medical Writer I Location - RAYNHAM, MA Job Ref No - # 15-01146 The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Synthes Strategic Medical Affairs Team for a wide ...