- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...strategic insights at the study team level. The Associate Director of Regulatory Writing must… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Director of Medical Device and Combination Product Quality Assurance, the Associate Director Quality Engineering & Quality ... and maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Analytics team members, Global commercial and New Product Planning teams, Medical Affairs, Regulatory Affairs, Legal, and Market Access. Collaborates closely ... to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading analyses of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ultimately ... and the quality system integrity expected by the customer. The Quality Director is committed to relentlessly pursuing zero defect manufacturing and maintaining… more
- Merck & Co. (Rahway, NJ)
- … devicesExperience with FAIR principles and other standardsExperience writing and maintaining process documentation#eligibleforERPCurrent Employees apply HERE ... Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is...will play a pivotal role in meeting cross-divisional and regulatory requirements by their strong scientific background, excellent communications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical ... change controls and maintain permanent inspection readiness and actively support regulatory inspections. This individual will also support the implementation of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... rare diseases and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025. This full time position… more
- J&J Family of Companies (Spring House, PA)
- Johnson & Johnson Innovative Medicine is recruiting for a Senior Director , Regulatory Medical Writing to be located in Springhouse, Pennsylvania, ... Kingdom, Raritan or Titusville, New Jersey United States of America. The Senior Director , Regulatory Medical Writing (Reg MW) is a highly experienced… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Jan 26, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: ... difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership, direction, and… more
- J&J Family of Companies (Spring House, PA)
- We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Oncology therapeutic area. The position may be ... This role will report directly to the Hematologic Malignancies Disease Area Head, Regulatory Medical Writing , Oncology. + Is the primary point of contact for… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...strategic insights at the study team level. The Associate Director of Regulatory Writing must… more
- Takeda Pharmaceuticals (Columbus, OH)
- …knowledge. **Job Description** **_Objective / Purpose:_** + Member of the Nonclinical Regulatory Writing and Submissions (NRWS) leadership who drives NRWS vision ... all programs and meet corporate goals by managing nonclinical regulatory writing activities. + Represent NRWS on...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Novo Nordisk (Lexington, MA)
- …into development plans, study designs, and regulatory submissions. Relationships The Associate Director , Medical Writing (ADMW) reports to a Director ... The Associate Director is an expert in medical writing and performs work independently with...9+ years of relevant experience. Minimum of 8 years clinical/ regulatory medical writing experience in… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Associate Director , Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage biotechnology ... from immunological diseases. Position Summary: Reporting to the Senior Director , Medical Writing , the Associate...all of Vera's drug development programs, producing high quality regulatory and clinical documents that meet regulatory … more
- Lilly (Indianapolis, IN)
- …**Additional Information:** + This role will report to the Associate Vice President, ExploR&D, Regulatory Affairs, Medical Writing , and Quality. + Core work ... de-risked opportunities to evolve how Lilly and LRL operates. The **Senior Director ** is responsible for managing all Regulatory activities (strategy and… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is...area or MBA + Minimum 5+ years' experience in regulatory affairs. + Experience working with Medical … more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the ... to electronic regulatory submissions and working with regulatory templates + Advanced understanding of medical ...and the ability to contribute to the development and writing of a regulatory strategy document +… more
- Kelly Services (South San Francisco, CA)
- …(eg FDA, ICH). + Experience with electronic submission systems (eg eCTD, SPL). + Regulatory writing and liaison experience is required. + Excellent written and ... in your career, trust **The Experts at Hiring Experts.** **Position Overview:** The Director , Global Regulatory Affairs is responsible for contributing to the… more
- Citigroup (Tampa, FL)
- **Audit Director -** **U.S. Regulatory Reporting Accuracy** The Audit Director is a senior level management position responsible for contributing to the ... and Citibank, their affiliates and of Citi's respective regulators, globally. The Audit Director - US Regulatory Reporting Accuracy is responsible for integrated… more
