- Legend Biotech USA, Inc. (Boston, MA)
- …Upper NY, VT, MA, RI, NH, CT, ME). Role OverviewAs part of the US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging ... Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one...in the treatment of multiple myeloma.Legend Biotech is seeking Senior Medical Science Liaison as part of the Medical… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Independently plan, execute ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… more
- ThermoFisher Scientific (Waltham, MA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... for talent development within the team. Reporting to the Senior Director of Regulatory Affairs ,...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Sumitomo Pharma (Boston, MA)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Takeda Pharmaceuticals (Boston, MA)
- …with US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub ... life-changing therapies to patients worldwide. Join Takeda as the Senior Manager, Global Labeling Devices. You will...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the ... process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- AbbVie (Waltham, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... and, if applicable, ensure direct reports follow requirements. + Ensures alignment of global regulatory strategies with Sr . Management. Under minimal… more
- Chiesi (Boston, MA)
- Sr . Director, Global Portfolio Strategy HIDO, Rare Date: Jan 17, 2025 Department: GRD Global Value & Access Job Type: Direct Employee Team: Mktg, Market ... monitor global market trends, patient demographics, competitor activities, and regulatory changes. Use this data to inform strategic decisions and adaptations +… more
- Sumitomo Pharma (Boston, MA)
- …internal company programs and external facing HCP and Payer interactions. The Sr . Director of Medical Affairs develops and maintains professional relationships ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Sanofi Group (Cambridge, MA)
- …experience partnering with cross-functional teams is strongly preferred (eg, Medical, Regulatory Affairs , Market Access, Communications). + This position may ... **Job title** : Global Public Affairs Head, Hemophilia **Location:**...reputation. + Develop and execute external engagement strategy for senior TA leadership to establish Sanofi's commitment to science… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Global Medical Affairs Lead, Plasma-Derived Therapies Innovations where you will ... regulatory , GEO, safety, compliance. + Acts as a senior company representative interacting with external scientific leaders, patient organizations, scientific… more
- Sanofi Group (Cambridge, MA)
- ** Global Medical Affairs Advisor** **-** **VIE Contract** + Location: United States of America, Cambridge + Target start date: 01/06/2025 iMove, the Sanofi VIE ... impact on the lives of countless people worldwide. As ** Global Medical Affairs Advisor** in our Medical...which serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical...Clinical summary and overview documents in eCTD format for global regulatory submissions + Shares knowledge and… more
- Bristol Myers Squibb (Boston, MA)
- …Collaboration : Serve as the primary point of contact for internal (Medical Affairs , Development, Commercial, Regulatory Affairs , Legal, and Compliance) and ... of a centralized capability and ensuring alignment with company goals and regulatory requirements. + Collaborate with senior leadership to define and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **POSITION ACCOUNTABILITIES:** + Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... true to the best of my knowledge. **Job Description** ** Senior Manager, US Medical Ad/Promo Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Sanofi Group (Cambridge, MA)
- **Job title:** Senior Global Medical Director Ophthalmology **Location:** Cambridge, MA **About the Job** In order to pursue Sanofi's purpose of "Chasing the ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...that address highest unmet needs. We are an innovative global healthcare company, committed to transforming the lives of… 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...cross-functionally with but not limited to Clinical Operations, Legal, Regulatory , Procurement, Patient Value Access and Safety. + Provides… more
