- 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
- 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
- Bausch + Lomb (Boston, MA)
- …the future. **Objectives** A member of the global technical CMC team for global regulatory CMC strategy for submissions and content of CMC dossiers for ... interdisciplinary project teams and to appropriate management level in Regulatory Affairs , R&D, TechOps and Supply Chain...documents in accordance with project timeline. + Coordinate with Regulatory Operations to ensure timely and accurate… more
- Merck (Boston, MA)
- **Job Description** **Health Systems Oncology Medical Affairs Director, US Medical Affairs - NorCal, NV, AZ** The Health Systems Oncology Medical Affairs ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...role also serves as a resource for the Medical Affairs (MA) management team on strategic planning and provides… more
- Merck (Boston, MA)
- …Research Laboratories is currently recruiting for a summer intern within US Medical Affairs Health Systems. The intern in this position will gain a broad ... understanding of Medical Affairs and access/reimbursement in US Health Systems (eg, payers,...for updates to both internal and competitor data and regulatory action across therapeutic areas to appropriately update the… 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 (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
- 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 (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
- 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
- Sanofi Group (Cambridge, MA)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... and gastroenterology experience required + Experience in pipeline, clinical development and/or medical affairs on a global or regional level including design of… 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
- Chiesi (Boston, MA)
- …support to multiple executives and team members. Previous experience working with Regulatory Affairs and Clinical Operations preferred. + Ability ... Sr. Administrative Assistant, Global Rare Diseases Date: Sep 30, 2024 Department:...consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification**… more
- Takeda Pharmaceuticals (Boston, MA)
- …development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the ... processes and tools to enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements. + Create and deliver training… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will...budget for assigned program(s) in close collaboration with GMAO Operations team + As needed, provide medical and scientific… more
- Sanofi Group (Cambridge, MA)
- …experts, statisticians, clinical operations personnel, medical writers, safety experts, regulatory affairs , medical affairs and external key opinion ... the Neurology TA (clinical pharmacology, Global Safety Officer, biostatistics, regulatory , Medical affairs and commercial teams) to facilitate the… more
- Takeda Pharmaceuticals (Lexington, MA)
- …teams on issue escalation and resolution + Set and maintain all relevant SOPs with Operations , Tax, Regulatory Affairs and Quality + Sustain GDP compliance ... of my knowledge. **Job Description** **Job Title** : Associate Director, US 3PL Operations Management Lead ( Operations & Analytics) **Location** : Lexington, MA… more
- Pfizer (Cambridge, MA)
- …Development & Operations , Medical Affairs , Commercial Development, Global Health and Value, Regulatory , Finance, Statistics, Clinical Pharmacology, ... to research, regulatory affairs , development, commercial, medical affairs , manufacturing and operations **Qualifications** Education and Experience + MD… more