- 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
- Takeda Pharmaceuticals (Boston, MA)
- …career grounded in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Head of Evidence ... Generation, Global Medical Affairs Oncology. You will work...will work cross-functionally with but not limited to Clinical Operations , Legal, Regulatory , Procurement, Patient Value Access… more
- Medtronic (Woburn, MA)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Regulatory Affairs Program Manager will lead the strategic planning and execution ... compliance. + Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements....+ Bachelors degree with 5+ years of medical device regulatory affairs experience OR + An advanced… more
- Teleflex (Chelmsford, MA)
- Sr. Regulatory Affairs Specialist **Date:** Oct 23, 2024 **Location:** Chelmsford, MA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... ID** :11196 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by...a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,… 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
- 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: health-care professional and provider interactions (HCP's,… more
- Merck (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations ) + Provide ... Medicine Operations , Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout sites… more
- Fresenius Medical Center (Waltham, MA)
- …May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff. **EDUCATION:** Bachelor's Degree required; ... **PURPOSE AND SCOPE:** Oversees all regulatory activities for new and mature products to ensure alignment and compliance with local and regional requirements as well… more
- Takeda Pharmaceuticals (Boston, MA)
- …with cross-functional team members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations , Drug Discovery ... FDA/EMA/PMDA regulations; ICH guidance; GLP/GCP requirements; SEND requirements, etc.). + Regulatory Affairs Credential (RAC-Drugs) is an advantage. + Strong… more
- Sanofi Group (Cambridge, MA)
- …including colleagues from the Global , Sales, Medical, M&S, Commercial Operations , Managed Markets, and Corporate Affairs . Additionally, you will lead ... **Job Title:** Head of US Commercial & Global Brand Lead, Alphamedix **Location** : Cambridge, MA...marketing brand teams, market research, sales, managed markets, sales operations , medical affairs , business development, regulatory… more
- Sanofi Group (Cambridge, MA)
- …scientific exchange and engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs to develop and launch ... **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About...of science to improve people's lives", Specialty Care Medical Affairs has a vision to be the leaders in… 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …environment to keep abreast of industry advances in technologies affecting Clinical Operations , Clinical Supplies, Regulatory Affairs , Data Management, and ... you to shine? Join us as a Senior Manager, Global Development Integration Office based in Cambridge, MA reporting...industry with a focus on Clinical Development and Clinical Operations . + Proven track record of leading and driving… more
- Sanofi Group (Cambridge, MA)
- …Collaborate with cross-functional teams, including but not limited to Sales, Marketing, Medical Affairs , Legal, and Regulatory Affairs , to ensure alignment ... **Job title** : Senior Director, Marketing Operations NA GTMC **Location:** Bridgewater, NJ or Cambridge,...(Hybrid role) **About the Job** We are an innovative global healthcare company, committed to transforming the lives of… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations , other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, ... + Develops, updates, and maintains GCP inspection procedures and guidelines within Global Clinical Trial Operations (GCTO). + Contributes to the development… more
- Sanofi Group (Cambridge, MA)
- ** Global Market Access & Pricing Specialist - VIE Contract** + _Location: USA, Cambridge_ + _Target start date: 01/02/2025_ iMove, the Sanofi VIE Program, is ... VIE_** _for Dupixent & Itepekimab Respiratory you will support the global market access plan and operation excellence workstreams including the coordination… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Safety Evaluation / Global Vaccines Safety Evaluation, Global Medical Affairs , Global Regulatory Affairs , Pharmaceutical Sciences, Statistical ... and compliance oversight for functions reporting into R&D CMSO and Vaccine Development, including Research, Global Development Operations , Global Patient… more