- Merck & Co. (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide clinical ... environment of mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Learn more about Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** The Global Lead Medical Affairs - Gastroenterology ... role requires the application of prior clinical knowledge and medical training to lead internal stakeholders within...+ Deep knowledge of the Gastroenterology therapeutic area and global understanding of medical affairs ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific ... Hematology to optimize department resources and evaluate trends in medical publications, and lead and/or participate in...needed, provide medical and scientific review of Global Medical Affairs Oncology materials… more
- Takeda Pharmaceuticals (Boston, MA)
- … medical /scientific director will provide scientific & team leadership, guidance across global medical affairs activities for advanced stage molecules ... will work in a multifunctional, matrix organization with other medical affairs functions ( global ...will contribute:** + Provide scientific/clinical expertise and leadership to lead development of the asset specific medical … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …emerging Neurology portfolio). This role will report to the Sr. Director, Global Medical Affairs , Franchise Lead CNS Early Assets. Assets under this ... experienced Medical Director of CNS Early Assets, Global Medical Affairs , responsible for... Lead CNS Early Assets. **Position Summary:** The Medical Director, Global Medical … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**ACCOUNTABILITIES** + Lead , design, and implement regional category strategies for Medical Affairs and global Market Access, ensuring alignment with ... US Medical Affairs leads category strategies and initiatives within USA Medical Affairs and Global Market Access, develops and executes innovative… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing innovative ... on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy with senior leadership of the TAU and where… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs (GMA) based...or marketed products. + Co-create the IEGP strategy with Medical Evidence Generation Lead and other evidence… more
- Sanofi Group (Waltham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... in helping our teams accelerate progress. As GRA CMC lead within our team, you'll have the opportunity to...the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device… more
- Parexel (Boston, MA)
- …professional to join our Global Regulatory Affairs team as a temporary ** Global Labeling Lead ** . This role will work closely our client and is integral ... clear, compliant, and high-quality documentation that enables safe and effective use across global markets? If so, we are seeking an experienced and highly motivated… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs , Neuroscience is responsible for developing innovative ... established andbuilding appropriate regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is accountable ... + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will...Advisor and function as the "R" in the core Medical , Legal, and Regulatory review functions within the Commercial… more
- Takeda Pharmaceuticals (Boston, MA)
- …The Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively ... regulatory reviewer in due diligence for licensing opportunities. + Partner with global market access colleagues to Lead interactions with joint… more
- Candela Corporation (Marlborough, MA)
- **Director, Global Regulatory Affairs ** Requisition Number **2872** Location **US - Marlborough, MA** State/Territory **Massachusetts** **Company Overview:** ... QS certifications (ie, MDR, MDSAP, etc.), and audit/inspection readiness. + Global accountability to establish/maintain a high-performance Regulatory Affairs … more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic and operational oversight ... of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions...layer and custom analytics capabilities in alignment with the Global Regulatory Analytics lead . + Working with… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and ... prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …my knowledge. **Job Description** **About the role:** Join Takeda as the Senior Director, US Medical Affairs - Head of Rheumatology in Cambridge, MA. This is a ... critical role within the US Medical Affairs (USMA) organization that reports to...of contact) on cross-functional / cross-division meetings (representation on global medical forums, commercial / product forums,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**About the role:** The **Head of Ethics & Compliance (E&C) for PDT R&D and Medical Affairs ** at the senior director level is a senior leader responsible for ... managing the E&C program across PDT R&D and Medical Affairs , and driving continuous improvement aligned...audits; and delivering E&C training. The role also supports global initiatives, digital ethics, and data privacy efforts, while… more
- J&J Family of Companies (Danvers, MA)
- …the continental USA. **Purpose:** The Manager, Medical Writing, Clinical & Regulatory Affairs will lead & support the development of regulatory documents and ... profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Writing… more
- Danaher Corporation (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... Biopharma sector. This position reports to the Director, Regulatory Affairs and is part of the Global ...this role, you will have the opportunity to: + Lead regulatory strategy and execution for external partnerships and… more
