- Takeda Pharmaceuticals (Boston, MA)
- …among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs , and commercial, to ensure the highest level of ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Hologic (Marlborough, MA)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... States Marlborough, MA, United States Join the Breast and Skeletal Health Clinical Affairs team as a **Clinical Project Manager,** leading major US and global… more
- Astellas Pharma (Westborough, MA)
- …talented counterparts in Quality Control (QC), Cytogenomics, Materials Management, and Regulatory Affairs . This role requires strong leadership, excellent ... world. We are committed to turning innovative science into medical solutions that bring value and hope to patients...related documentation to ensure alignment with internal procedures and regulatory requirements. + Lead, coach, and develop a team… more
- Takeda Pharmaceuticals (Boston, MA)
- …with the ability to make tough talent decisions. + Deep expertise in ** Regulatory Affairs , Clinical Development, and R&D technology ecosystems** (eg, Veeva Vault ... and delivery of technology solutions that enable global R&D, Regulatory , or Global Development functions. This role owns a...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Hologic (Marlborough, MA)
- …product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs , and Manufacturing Engineering teams to embed quality and compliance ... and requirements traceability. + Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. + Proficiency in statistical… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, ... and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's… more
- ConvaTec (Lexington, MA)
- …full-time Convatec CSMs). **Principal Contacts & Purpose of Contact** Internal - Medical Affairs , Clinical Operations (Study Management, Site Management, Data ... with cross functional team members including, but not limited to, regulatory , R&D, project/program management, data management, and medical monitors.… more
- Takeda Pharmaceuticals (Boston, MA)
- …The Manager, Global Scientific Communications is a dynamic role within Global Medical Affairs that collaborates with cross-functional partners to deliver various ... providing quick answers to common queries. + May provide Medical Affairs representation during concept design of...in epilepsy is an asset + Familiarity with international regulatory and legal guidelines regarding Medical Communication… more
- Takeda Pharmaceuticals (Boston, MA)
- …patient access. **Job Requirements:** + Graduate student in public health, pharmacy, regulatory affairs , health policy, global health, or a related discipline. ... supply routes can expand patient access. + Exposure to cross-functional collaboration with Regulatory , Legal, Medical , and Access teams. + A portfolio-ready tool… more
- Dana-Farber Cancer Institute (Boston, MA)
- …setting or comparable technology orientated business environment preferred. + Knowledge of regulatory affairs , research ethics, and the responsible conduct of ... physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. + Oversight of the clinical trials start-up… more