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regulatory affairs in Newark

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    1. Associate Director, Drug Safety & Medical Evaluation

       Associate Director, Drug Safety Medical Evaluation:  Near Princeton, NJ area SUMMARY Provides medical review and evaluation of safety information and adverse event reports for both marketed and investigational medicinal products and medical devices. Performs scientific review and evaluation of individual and aggregate adverse events reports, and assesses them in accordance with ...

    2. Medical Writer - Regulatory and Medical Affairs (97976)

      Job Description: A Medical Writers (Regulatory and Medical Affairs) is needed for 12-month contract positions at major pharma company in Northeast. Minimum Requirements Education, Experience and Skills: PharmD, PhD, or MD with a minimum of 2 years experience in medical writing. Oncology experience is strongly preferred. Pharmaceutical industry experience or Medical Communications ...

    3. Regulatory Affairs Specialist

      POSITION DUTIES:• Provide Regulatory Support for Current Products and Development Projects Execute strategy and provide regulatory support and input. Deliver projects and other initiatives to progress current product portfolio by providing regulatory direction and support to stakeholders: o Collect and collate data required for registration submissions. o Prepare submission packages for the ...

    4. Regulatory Affairs Manager

      Job Description: This role will be part of the Regulatory Organization supporting the business through the preparation of product submissions, license renewals, label & advertising reviews, product development team participation, and other regulatory affairs support activities. This position will interface with key business and cross-functional stakeholders to ensure that the commercial ...

    5. Food Technologist

      We are seeking a highly motivated R&D Technologist to join a growing highly successful business, Premio Foods’ Research and Development team. The Technologist will be responsible for performing product development work to meet project objectives, supporting innovation and brand maintenance initiatives. Must be able to perform multiple, simultaneous projects. Our mission is to improve the ...

    6. Medical Director Medical Affairs Dermatology / Sr Director Dermatology

      Do you possess cutting edge experience in drug development and medical affairs, extraordinary leadership competencies, and the perspective needed to develop medical strategy around new Dermatology medicines? Come to an industry leader where you will help drive the US Medical strategy for development and marketed products in the Dermatology Therapeutic Area. The selected candidate will ...

    7. Medical Director Medical Affairs Rheumatology

      Do you possess cutting edge experience in drug development and medical affairs, extraordinary leadership competencies, and the perspective needed to develop medical strategy around new Rheumatology medicines? Come to an industry leader where you will help drive the US Medical strategy for development and marketed products in the Rheumatology Therapeutic Area. The selected candidate will ...

    8. Medical Director Medical Affairs Dermatology / Sr Director Dermatology

      Do you possess cutting edge experience in drug development and medical affairs, extraordinary leadership competencies, and the perspective needed to develop medical strategy around new Dermatology medicines? Come to an industry leader where you will help drive the US Medical strategy for development and marketed products in the Dermatology Therapeutic Area. The selected candidate will ...

    9. Drug Safety Physician

      Large International Sponsor Company with an office in the Greater Parsippany, NJ area is seeking a Drug Safety Physician for a 6 month contract with the option to be extended. The ideal candidate: Acts as the primary contact point with PVE in HYD, CSS and co-ordinates product-specific activities. Performs medical review of individual SAEs from clinical trials with the support of the PVE as ...

    10. Executive Medical Director - Neurodegenerative Drug Development

      Lead 6 or more Group Medical Directors responsible for multiple Clinical Development programs, provide strategic product development plans, medical and scientific expertise and strong knowledge of regulatory compliance requirements. Requirements: *** Medical Doctorate or Doctorate of Osteopathic Medicine. *** 10+ years experience in clinical trial activities, academic research or ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    11. Regulatory Affairs Manager, EPA

      Regulatory Affairs Manager, EPA - Near Jersey City, NJ   The Regulatory Affairs Manager is responsible for managing the Regulatory Affairs department. This individual will work with cross functional departments to ensure that all products are in compliance with the appropriate government agency requirements. He/she will represent Regulatory in project team meetings and provide the relevant ...

    12. Regulatory Affairs Manager, FDA

      Regulatory Affairs Manager, FDA - Jersey City, NJ area Handles day-to-day regulatory affairs matters and regulatory compliance relating to new food, treat and consumable product development and existing product lines coordinating such effort with relevant stakeholders such as Legal, QA, Marketing, Packaging and R&D departments. The Regulatory Affairs Specialist provides updates on existing ...

    13. Regulatory Affairs Specialist - Pharma Advertising And Promotion Submi

      Seeking individual with experience interfacing directly with officials from the FDA Office of Prescription Drug Promotion (OPDP). Shall: *** Review advertising and marketing materials to ensure submission forms meet regulatory compliance criteria. *** Communicate with key decision makers in the Office of Prescription Drug Promotion. *** Review and approve all documents and forms ...

      No PartTime
      No Contract
      No Internship
      No Freelance
      No Telecommute

    14. Pharmacovigilance Leader

      Minimum Requirements: • Solid knowledge of MedDRA. • At least 3 years of experience in pharmacovigilance. • At least 3 years of experience in Argus medical review of SAEs (including writing Dear Investigator Letters (expedited reports) and able to work independent in the coding and causality/expectedness assessment of adverse event reports. • Experience providing medical input to aggregate ...

    15. Clinical Compliance Manager

      The individual in this position will interface with Corporate Clinical Affairs (CA) and divisional Clinical Affairs staff members involved with the management and execution of clinical trials to ensure compliance with the laws and regulations relevant to clinical studies, and to the Company’s policies and procedures (Clinical Standards, CA-STDS). Planning and conducting and report-writing of ...

    16. 97567 - Sr. Regulatory Affairs Therapeutic Area Associate

        Minimum Requirements: • Bachelors’ Degree required; Life Science preferred. • Minimum of 3-5 years’ experience required, Pharmaceutical industry, laboratory, or clinical research position, Regulatory Affairs preferred. • Intermediate proficiency in Microsoft Office Suite required. • Strong attention to detail. • Commitment to quality of all assigned projects. • Excellent written and oral ...

    17. Director, Medical Science

      Director, Medical Science, Summit NJ area MUST HAVE MD-PLEASE DO NOT APPLY IF NOT AN MD SUMMARY The Director of Medical Science (MS) is responsible for providing input into the Global Project Teams in planning, designing, developing, executing and interpreting clinical studies, including but not limited to those carried out in North America (NA) the global development program. The ...

    18. Senior Manager, Regulatory Affairs

      Senior Manager, Regulatory Affairs   SUMMARY The Senior Manager, Regulatory Affairs (RA) is responsible for supporting the preparation and implementation of regulatory strategies to facilitate the development and approval of new drugs/biologics in the US. Responsibilities include communication and coordination with global project team members from domestic site, Japan site, Europe site, ...