- 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
- 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 (Lexington, MA)
- …teams. Additionally, it will engage with other business units and functional groups, such as Global Medical Affairs , Oncology, and Medical & Commercial ... and corporate memberships backed entirely or partially by US Medical Affairs . * Lead the...you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation,… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US medical ... Scientific Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in alignment with business objectives.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products include genetically modified ... GRA CMC knowledge underpinned by a deep understanding of global drug development and regulatory essentials to address and...standards. + When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (eg,… more
- Evident Scientific (Waltham, MA)
- Executive Director, Regulatory Affairs & Quality Assurance. Job ID #: 2023 Company: Evident Posting Date: Jun 3, 2025 **Working Location:** **MASSACHUSETTS, ... lives, together.** **Job Description** The Executive Director, Quality and Regulatory Affairs (Exec Dir QARA), will oversee the Quality, Regulatory and Environmental… more
- AbbVie (Waltham, MA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory ... that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a...TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling… more
- Sanofi Group (Framingham, MA)
- …projects. The incumbent will work closely with key stakeholders including clinical, medical affairs , Industrial Affairs (Device Development, manufacturing, ... portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device...deliverables. + Review and approve design control deliverables. + Lead and/or support global filing and lifecycle… more
- Fresenius Medical Center (Waltham, MA)
- …formatting, technical, and regulatory standards. + Collaborates cross-functionally with Regulatory Affairs , CMC, Medical Writing, Quality, and other stakeholders ... management systems. In addition to publishing responsibilities, this role will lead and support the creation, implementation, and ongoing maintenance of departmental… more
- Bristol Myers Squibb (Devens, MA)
- …Regulatory Affairs and Brand teams. The individual provides end-to-end global quality oversight of all cell therapy development programs for vector and ... careers.bms.com/working-with-us . **Position Summary** The Executive Director, Cell Therapy Global Product Quality (CTGPQ) is responsible for development and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …project management and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored ... and program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory, CMC or other drug… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …Regulatory Affairs and other functions + Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...more than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...important role will be a key partner to the global BD team, ensuring that the function's perspective is… more
- ConvaTec (Lexington, MA)
- … medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management ... wide range of stakeholders, including Applied Research, New Product Development, Marketing, Medical and Clinical Affairs , Market Access, and External Innovation… more
- Hologic (Marlborough, MA)
- …we'd love to hear from you! **Knowledge** + Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements. ... you a seasoned regulatory professional ready to make a global impact in the medical device industry?...+ A minimum of 5 years of experience in Medical Device Regulatory Affairs , with a proven… more
- Takeda Pharmaceuticals (Lexington, MA)
- …functions and device development teams + Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial ... and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves… more
- Actalent (Framingham, MA)
- Job Description Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and laboratory ... cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure accurate, complete, and timely… more
- Grifols Shared Services North America, Inc (Worcester, MA)
- …Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being ... and clinical insights aligned with the product's label to relevant customers. + Lead in-depth discussions of disease state, and treatment approaches. + Keep abreast… more