- Leica Biosystems (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... the Biopharma sector.This position reports to the Director, Regulatory Affairs and is part of the Global ...fully remote.In this role, you will have the opportunity to: Lead regulatory strategy and execution for external partnerships and… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …divisional initiatives and may contribute to corporate, cross-divisional, and global initiatives Accountabilities: Program Leadership : Provides strategic scientific ... leadership and program management for multiple global CMC development teams dealing with complex development programs...expected to advance not only the program teams they lead but also other teams that are facing unique… 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)
- …medical /scientific director will provide scientific & team leadership, guidance across global medical affairs activities including evidence data ... 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
- 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
- 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)
- …the future while fully promoting the in-line portfolio. + Lead the Takeda Global Oncology Medical Affairs (GMAO) strategy. + Implement and execute all ... and lead the further development of the global oncology medical team. This is a...development assessment. + Attract, develop and retain a best-in-class global medical affairs organization, role… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** : Reporting to the Vice President, Global Medical Affairs , the Executive Director, CNS Strategy, Global Medical Affairs is a ... CNS products. This individual is the therapeutic level lead and collaborates with other functional and department leaders...but are not limited to the following: + Represents Global Medical Affairs on extended… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Head of Global Medical Affairs , Solid...and lead an innovative, agile, and diverse global medical affairs team + ... leader to join our team as the Head of Global Medical Affairs for Solid...and customer needs in the solid tumors space + Lead the development and execution of medical … 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
- Fresenius Medical Center (Waltham, MA)
- …products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + **Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the ... for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets. + Work closely with commercial, clinical/ medical , and… 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
- 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
- Sanofi Group (Cambridge, MA)
- …Director collaborates closely with cross-functional teams, including Global Regulatory Affairs , Clinical Development, Safety, and Medical Affairs , to ... **Job Title:** Associate Director, Global Regulatory Affairs - Global...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
- Merck (Boston, MA)
- …Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... by: + Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines. +… 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
- Takeda Pharmaceuticals (Boston, MA)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC. **How you will...ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary:** The Associate Director of Global Medical Affairs Omnichannel will be responsible for developing and leading the omnichannel strategy ... for Global Medical Affairs across all...needs and priorities are represented in enterprise-wide initiatives. + Lead the development of requirements for technology platforms that… more
