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  1. Clinical Research Manager II -  105023

    Clinical Research Manager II – 6 month contract Support US efforts in the planning, execution and reporting of US Clinical Data and Medical Affairs (CDMA) clinical trials in Oncology: Implementation of clinical trials in the United States (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), within a cross functional team and with oversight from the Associate Director.  Interfacing with the hematology therapeutic area global and US clinical team members, ...

  2. Head of Global Quality Management

      As Head of Global Quality Management in the Quality Assurance group, you will report to the Regulatory Affairs Director and coordinate the implementation of the Global Quality Management and Assurance strategy for the Scientific Division and Phase IV studies. You will supervise more than 20 employees worldwide (Europe, North America, and Asia).  Accountability Responsibilities: Implement the quality systems to fulfil regulatory requirements applicable to Company (GLP, GCP, GMP, GDP) Define ...

  3. Clinical Research Manager II- 94440

    Minimum Requirements: Prior experience with Implementation of clinical trials in the United States safety, data consistency, trial timelines, budget, resources, eligibility and enrollment.   Education: Bachelor Degree required   Job Description: Support US efforts in the planning, execution and reporting of USCDMA clinical trials in Oncology. Implementation of clinical trials in the United States (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), ...

  4. Clinical Research Manager II

    We have a Contract opportunity with a prominent client for a Clinical Research Manager II in East Hanover, NJ.   Duties               Support US efforts in the planning, execution and reporting of USCDMA clinical trials in Oncology. Implementation of clinical trials in the United States (safety, data consistency, trial timelines, budget, resources, eligibility and enrollment), within a cross functional team and with oversight from the Associate Director. Interfacing with the hematology ...

  5. Director of Regulatory Affairs

    Seeking a Hands-On Director of Regulatory Affairs. Apply today! My client is a biopharmaceutical company that is focused on developing breakthrough treatments for human disease. Lexicon has advanced multiple drug candidates into clinical development. They are presently devoting most of their resources to the development of their two most advanced drug candidates. LX4211 is an orally-delivered small molecule drug candidate developed as a treatment for type 1 and type 2 diabetes. They have completed ...

  6. Regulatory Affairs Segment Leader Job

    GE Healthcare GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. This is a highly visible and strategic role within RA that will help shape the global development strategy and life cycle management strategies. This role reports to the Global Head of RA and will be part of the RA Leadership Team. The Regulatory Affairs Segment Lead will be responsible for leading, setting, and driving a robust ...

  7. Regulatory Affairs Specialist (2098)

    We are currently seeking a Regulatory Affairs Specialist for a 9+ month contract in Florham Park: SUMMARY **This is a speciality role-need someone with the following skill sets** This position will be responsible for FDA Site Registrations, Pharma Wholesaler State License/Permit Registrations/Renewals, Customer Audit Scheduling, Animal Nutrition permits and tonnage reports and license database, issuing LOAs, annual DEA registrations. In addition, the role coordinates the systems part of ...

  8. Sr. Regulatory Affairs Associate

    *Experience in sterile injectables is required Roles and Responsibilities: Compile ANDA/NDA dossiers, including:  requesting necessary documents from CMO/CRO, performing pdf CRO conversion and size reduction, bookmarking, and compiling Modules. Ensure quality submission. Manage regulatory document submissions, including: uploading all modules to eCTD software, performing hyperlinking, submitting through ESG, and sending notice to management and partners. Create draft labeling and SPL for ANDA ...

  9. Pharmaceutical Recruiter

      Come find out why Fortune 100 pharmaceutical & biotechnology clients consistently rank SciStaff Services, LLC as their business partner of choice when identifying contract and consultant talent in the areas of clinical development, medical affairs, regulatory affairs, pharmacovigilance, medical writing, data management, quality assurance and scientific roles. While many of our competitors have faced insolvency under a tough economy, we have actually hit record sales.  Come find out why.   We ...

  10. Pharmaceutical Recruiter

      Come find out why Fortune 100 pharmaceutical & biotechnology clients consistently rank SciStaff Services, LLC as their business partner of choice when identifying contract and consultant talent in the areas of clinical development, medical affairs, regulatory affairs, pharmacovigilance, medical writing, data management, quality assurance and scientific roles. While many of our competitors have faced insolvency under a tough economy, we have actually hit record sales.  Come find out why.   We ...