- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required ... + A seasoned, experienced professional with a full understanding of Regulatory Operations ; resolves a wide range of issues in creative ways. +… more
- Takeda Pharmaceuticals (Boston, MA)
- … Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to ... regulatory sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team, influencing the operations and future strategy of… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in ... data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team,...data that will resolve or simplifies complexity between commercial, operations , and strategy. + Resilient and comfortable working through… more
- Philips (Cambridge, MA)
- …right fit if:** + You have a minimum of 10 years' experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical ... The Director of Regulatory Affairs & Quality will lead...and/or Quality teams. + You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485,… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead, is responsible for development… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participates in strategic and operating planning activities in partnership with the Global Head of Clinical Affairs , in translating corporate and divisional ... are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards. + As a… more
- Orchard Therapeutics (Boston, MA)
- … Affairs Location: United States, Boston, MA Job Summary The Medical Affairs Operations and Medical Information Scientist will be accountable for Medical ... grant funding requests . Medical Information / Medical Affairs functional and departmental operations - Development...teams - Medical Communications / Publications - Regional and global operations teams - Cross-functional teams (Patient… more
- AbbVie (Waltham, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc ) as they relate ... assist with the scientific review, development, execution and communication of affiliate/area/ global medical affairs sponsored or supported clinical research… more
- Sumitomo Pharma (Boston, MA)
- …Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and ... with the US Field Medical team, Medical Communications & Operations , Japan medical affairs colleagues, RWE (Real...global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada… more
- Bausch + Lomb (Boston, MA)
- …**Contacts (Internal And** **External)** + **Internal:** US Medical Affairs , Regulatory Affairs , Clinical Operations , Research & Development/Life Cycle ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...eye health in the future. **Position** **Summary** The Medical Affairs Director provides support to the Medical Affairs… more
- AbbVie (Waltham, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc.) as they relate to ... medical and scientific strategic and operational input into core medical affairs activities such as: health-care professional and provider interactions (Payers,… more
- AbbVie (Cambridge, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc.) as they relate to ... medical and scientific strategic and operational input into core medical affairs activities such as: Securing insights, developing scientific value, advancing… more
- AbbVie (Cambridge, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc.) as they relate to ... standards, SOP's and all other quality and compliance standards in Medical Affairs . + Providing input into externally facing materials for use (ie Congress… more
- AbbVie (Cambridge, MA)
- …scientific and medical activities with internal stakeholders (ie commercial, clinical operations , discovery, statistics, regulatory , etc.) as they relate to ... MA preferred. Will consider remote candidates. Purpose The Assistant Director, Medical Affairs has a key role within the Psychiatry Therapeutic Area. Working under… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs SOPs and processes. + Coordinate with Pharmacovigilance, Quality and Regulatory Affairs to respond to external audits and requests from external ... **About the role:** You will manage the operational conduct of Medical Affairs Company Sponsored Studies (MACS), Investigator Initiated Research (IIR) and Externally… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …application is true to the best of my knowledge. **Job Description** Global Patient Access Operations Lead **Takeda Pharmaceutical** **Cambridge, MA** **About ... to expanded access programs to cross-functional teams + Collaborates with cross-functional, global and local teams (eg Medical affairs , Clinical supplies R&D)… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and executing expanded access/Compassionate use programs. + Comprehensive knowledge of global regulatory requirements and guidance related to Patient Access. ... and collaborate effectively with other interfacing Takeda functions (eg Medical Affairs , Global Manufacturing Services, Ethics and Compliance). + Excellent… more
- Takeda Pharmaceuticals (Boston, MA)
- … global brand strategy, incorporating cross-functional strategies (eg Commercial, Regulatory , and Region/country medical partners, and others, as appropriate). + ... Lead development and execution of the global medical affairs (GMA) strategic and tactical...patient strategy, digital). + Work with the GMUH & global medical strategy & operations (GMS&O) lead… more
- Sanofi Group (Cambridge, MA)
- …and market access on therapeutic solutions to support patients' needs. Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... experience highly preferred. + Experience in pipeline, clinical development and/or medical affairs on a global or regional level (commercial experience a… more