- ThermoFisher Scientific (Greenville, NC)
- …to present services to sponsors and prepare effective proposals for Pharmacovigilance and Regulatory Affairs activities which include the specific value proposition ... instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees Thermo Fisher Scientific… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** **About the role:** Join Takeda as an Executive Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation ... of company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice President, Therapeutic… more
- CSL Behring (King Of Prussia, PA)
- As a true expert in the responsible TA, the Executive Director , will lead the development and execution of Medical Affairs strategies and tactics in support of ... and In-line products, International Medical Affairs, CRD, R&D, Global Clinical Safety & Pharmacovigilance (GCSP) and will serve on the Safety Management… more
- AbbVie (North Chicago, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Executive Medical Director is responsible for the safety strategy for Hematology late-stage ... in the Oncology TA. The Executive Medical Director will be the oncology safety team...Clinical Development + Direct Experience in NDA submissions from pharmacovigilance /Clinical development side is required. + At least 3… more
- BeiGene (San Mateo, CA)
- The Executive Medical Director will support BeiGene Clinical and Medical assets within the Hematology franchise by successful development of early and late phase ... colleagues in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational research.… more
- AbbVie (Jersey City, NJ)
- …trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the ... key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission - … more
- Amgen (Washington, DC)
- …(SAT) and Global Safety Team (GST) and will be a core member of the Executive Safety Committee (ESC). In addition, you will participate as a member of the ... proud of. **Global Safety Officer (GSO),** **Global Safety Medical Director - Obesity** **, US...and related conditions experience. + 2 years of industry pharmacovigilance (PV) experience + Product safety in… more
- AbbVie (Irvine, CA)
- …defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety , Regulatory and Medical Affairs Quality Standards ... assurance excellence mindset. The role reports to the Senior Director of Safety , Vigilance and Medical Affairs...to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety , Regulatory Affairs and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …knowledge. **Job Description** **About the role:** Join Takeda as an Associate Director , Market Research and Competitive Intelligence, where you will be responsible ... recommendations and market intelligence insights to commercial brand, medical, forecasting, and executive teams to inform decision making. + Owns and executes CI… more
- Lilly (Indianapolis, IN)
- …providing de-risked opportunities to evolve how Lilly and LRL operates. The **Senior Director / Executive Director ** is responsible for managing all Regulatory ... focus on US, UK, EU, and Canada. The Senior Director / Executive Director works with a...and test key scientific hypotheses, discharge risks regarding molecule safety and efficacy, and enable effective decision-making related to… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... suffering from immunological diseases. Position Summary: We seek an Associate Director , Quality Assurance to join an experienced, fast-paced and collaborative team.… more
- BeiGene (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... **General Description:** The Director , Clinical Science will support BeiGene Clinical and...applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports. + Clinical sections of Health Authority… more
- ThermoFisher Scientific (Greenville, NC)
- … will provide medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department. **A day in the Life:** ... and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at… more