- CSL Behring (Waltham, MA)
- …and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, 'One GRA ... from PST, CDT, SMT and related delivery teams. May lead discussion at Global Regulatory Forum (GRF)...continually refine ways in which products can address unmet medical needs and help patients lead full… more
- Merck & Co. (Boston, MA)
- …developing and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory, analytical, and ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… 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
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is...ensures appropriate communication, resolution and/or escalation as needed + Lead global filing and lifecycle management activities… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA, Morristown, NJ **About the Job** Are you ready to shape the future of ... strategic negotiations with health authorities worldwide. Within Sanofi's Global Regulatory Affairs (GRA) CMC organization, the CMC Lead role offers the… 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
- 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
- Sanofi Group (Cambridge, MA)
- …labeling leadership to cross-functional teams (Regulatory Strategy, Clinical Development, Medical Affairs , Pharmacovigilance, Market Access ). + Contribute ... **Job Title:** Director, Global Regulatory Affairs - Global...was possible. Ready to get started? **Main Responsibilities:** + Lead the development, maintenance, and alignment of global… 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
- Pfizer (Cambridge, MA)
- … Director, mRNA Vaccines, the incumbent will be responsible for executing US medical affairs activities. This will entail the following:** + Support the ... Medical objectives + Partner with Public and Corporate Affairs to expand Vaccines Medical footprint with...Immunization Managers, Professional Societies + Brand Plan Development: Provide medical input into global brand strategies and… 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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Diagnostic and Scientific Affairs Director **Location:** Cambridge, MA **About the Job** We are seeking a highly motivated and ... scientifically skilled professional to join the Global Diagnostics & Scientific Affairs team. This...translational tests) to meet clinical and regulatory needs. + Lead the transfer of assays from internal development to… 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
- 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
