- 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- …Development functions in support of IT - Medical Affairs , Regulatory Affairs , Global Patient Safety, Clinical Operations , BioStats & Data Management, ... The Business Analysis & Operations Senior Manager will drive consistency across the Global Development (GD) IT team & IT community. This role will be a key team… more
- Sanofi Group (Framingham, MA)
- **Job title:** Manager, Global Regulatory Affairs CMC + Location: Bridgewater, NJ **About the job:** The Manager, Global Regulatory Affairs CMC ... biological entities, vaccines. The incumbent creates collaborative working relationships with Global Regulatory Affairs (GRA), Regional GRA, Country… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs , Marketed Products in Cambridge, MA ... Prior experience must include: Vendor and Client Management for Regulatory Operations - Manage relationships with vendors...Health Canada, and other international health authorities - Support regulatory team and Global Regulatory … 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
- Edwards Lifesciences (Boston, MA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... international regulatory environments....and resolving project-related issues with cross-functional partners (eg, Clinical Affairs , Quality, R&D, etc.) + Act as a technical… more
- Merck (Boston, MA)
- …own and other's (team's) results. + Have broad experience in Animal health commercial operations , R&D, and Regulatory Affairs + Expertise in project ... Consumer Affairs + Research and Development + Supply, Quality, Regulatory + Strategic Development and Innovation, Marketing, Sales, Salesforce Enablement and… 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
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk...Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead… more
- Harvard University (Cambridge, MA)
- …Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the ... protocols and materials, protocol modifications and reportable information, as well as regulatory compliance and operations + Serving as the intermediary between… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... + Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory ...Regulatory Team (GRT) + Liaises with US Labeling Operations , EU Labeling Operations , Labeling Devices Lead… more
- Merck (Boston, MA)
- …relevant regulatory guidelines and compliance requirements pertaining to Medical Affairs operations , and, preferably, experience in navigating regulatory ... Global Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that...business, or healthcare + 5 years of relevant Medical Affairs experience (eg, Knowledge Management, Medical Operations )… more
- Sanofi Group (Cambridge, MA)
- … Medical Director, Amlitelimab **Location:** Cambridge, MA or Bridgewater, NJ Within the Global Medical Affairs Immunology team, we are proud to support Sanofi's ... critical in helping our teams accelerate progress. Join our Global Medical Immunology team as the Global ... brand teams, market research, sales, managed markets, sales operations , business development, regulatory , research & development,… more
- AbbVie (Waltham, MA)
- …with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director, or Director), in the ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Novo Nordisk (Lexington, MA)
- …Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations , Regulatory Affairs , Data Management, Biostatistics, Non-clinical, ... About the Department Our East Coast Global Development Hub brings together the best minds...multiple innovative modalities and therapeutic areas. Our East Coast Global Development Hub merges biotech speed and agility with… more
- Pfizer (Cambridge, MA)
- …In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations , the CS is responsible for execution and project ... the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations , Medical/Scientific Affairs , Regional, Pfizer laboratory assay group, and… more
- Pfizer (Cambridge, MA)
- …The Specialty Care Operational Excellence Director role is an integral member of the Global & US Medical Affairs Teams, and the Operational & Change Excellence ... US Field Medical Lead and closely collaborates with the Global Medical Affairs and US Categories Medical...functions desirable. + Prior experience in Project Management, Business Operations . + Expertise or experience in Specialty care is… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real-World Evidence (RWE) Platform is responsible for establishing global scientific ... outcomes research, RW-relevant health informatics, and biostatistics talent from global , international developed market (IDM) and emerging markets (EM) into… more
- J&J Family of Companies (Cambridge, MA)
- … operations , project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical ... medical writing, clinical pharmacology, legal, finance, quality assurance, strategy and operations , global medical affairs , health economics, epidemiology… more