- Omni Inclusive (Danvers, MA)
- …providing support for cross-functional initiatives. Major Responsibilities: Operations Coordinator for Global medical Affairs Teams Learns about the Danaher ... effectiveness, Medical insights generation, and reporting on key projects Support Global Medical Affairs external solution vendor tools and insights reporting.… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …support key decision-making, drive conclusions and develop next steps Work closely with Regulatory Affairs , and other cross functional team members to ensure ... will be located in the Waltham office. The Medical Director is responsible for global pharmacovigilance (PV)...and other periodic reports Contribute to preparation of relevant regulatory documents and responses to regulatory agency,… more
- Akebia Therapeutics (Cambridge, MA)
- …functional groups such as monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA. The individual will also be responsible ... we are all in, are you? Job Summary: Reporting to the Sr. Director , Clinical Operations, the successful candidate will provide operational leadership and expertise… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) ... Your skills could be critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Fresenius Medical Center (Waltham, MA)
- …+ 12+ years of experience in regulatory affairs , focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. + ... Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical...a Master's, PhD, or MBA is highly preferred). + Regulatory Affairs Certification (eg, RAC) is preferred.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC) for investigational and ... this key leadership role, you will build and oversee Global Regulatory Science and Regulatory ...position you will build and lead a cell medicine regulatory affairs team and provide regulatory… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion **Location:** Cambridge, MA or Morristown, NJ **About the job** Are you ready to ... and direct reports. + In conjunction with the Sr. Director /Product Support Head, imparts senior regulatory guidance...8+ years of experience within pharmaceutical or medical device Regulatory Affairs + Successful track record of… more
- BeOne Medicines (Cambridge, MA)
- BeOne Medicines USA, Inc. (f/ka BeiGene) seeks Director , Regulatory Affairs in Cambridge, MA, USA: **Job Duties:** + Provides high level regulatory ... expedite approvals of product and labeling changes. + Maintains awareness of global regulatory environment and assess impact of changes on business and product… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …plans in Immunology- and Infectious Disease-related therapeutic areas. Develop and lead Medical Affairs initiatives and strategies aligned with the global and US ... Innovation Office and commercial functions. 2. Support development of global and US medical affairs plans in...**Pay Scale:** The estimated pay scale for the Medical Affairs Scientific Director 2 role based in… more
- Philips (Cambridge, MA)
- ** Director , Regulatory Affairs - Software and...for the Ultrasound business. **Your role:** + Lead a global Regulatory Affairs team for end-to-end ... Artificial Intelligence (Ultrasound)** The Director , Regulatory Affairs -SW and AI will lead...the hiring and development of critical talent within the global regulatory affairs team through… more
- Sanofi Group (Cambridge, MA)
- …the IEGP. The Medical Director will collaborate with internal experts from Global and Local Medical, Clinical Development, and Regulatory teams to develop, ... **Job title** : Global Medical Director , Evidence Generation -...with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …(Line) Expertise:** + Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ... communication plans through close collaboration with cross-functional teams (including Medical Affairs , Clinical Development, Regulatory Affairs , Commercial,… more
- Sanofi Group (Cambridge, MA)
- … etc.) + Partner effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR ) to influence the ... **Job Title:** Sr. Director , Global Market Access and Pricing...with: + GPT members (NPP/GBL, GPH, GPM, Clinical leads, Regulatory Affairs leads, Medical ) + HEVA… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Pipeline Communications (Immunology) **Location:** Cambridge, MA **About the Job** Ready to push the limits of what's possible? ... make an impact on millions around the world. As ** Director , Global Pipeline Communications (Immunology)** , you...programs and key markets as well as Science/R&D Communications, Global Media Relations, Investor Relations and Public Affairs… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Job Description** **OBJECTIVES:** + Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams + Leads ... GMA-driven evidence generation, taking into consideration the medical, scientific, regulatory and commercial considerations + Supports multi-disciplinary matrix teams… more
- Sanofi Group (Cambridge, MA)
- …diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department ... **Job Title:** GRA Device Lead ( Director ) **Location** : Morristown, NJ, Cambridge, MA, Framingham,...within Global Research and Development. Sanofi's global regulatory affairs (GRA) function… more
- Sanofi Group (Cambridge, MA)
- …Gastro **Location** : Cambridge, MA, Morristown, NJ, **About the Job** Sanofi is recruiting a Director US Medical Affairs . The Director will report to the ... strategic objectives. + Reviewing and approving medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and Commercial.… more
- Grifols Shared Services North America, Inc (Medford, MA)
- …for the therapeutic area(s). + Partners with the Medical Directors, National MSL Sr Director , and North America Medical Affairs Sr Director to develop ... + Participates and contributes in cross-functional teams (eg, sales, marketing, global medical affairs ) regarding field-based activities, medical insights,… more
