- Takeda Pharmaceuticals (Boston, MA)
- …for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the ... regulatory data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications ... franchise structure.** **Strategic and thought leadership experience in medical affairs and Neuroscience.** **Experience successfully leading global … more
- 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 ... Responsibilities:** + Be a strategic thought partner to the Head of Regulatory about complex problems, current... sites/functions. + Serve as a member of the Global Regulatory Affairs Leadership Team,… more
- Philips (Cambridge, MA)
- …manufacturing procedures to maintain quality and regulatory compliance. + Reporting to the Head of Regulatory Affairs for AM&D, you will communicate with ... The Senior Regulatory Affairs Program Manager will play...& Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Director, Medical Affairs Oncology Digital & AI Innovation will report to the Oncology AI Innovation Head . This is a vital role within the ... acting as an operational business partner across Oncology Medical, International Medical Affairs , and Pfizer US (Medical Platforms) for all digital and AI… more
- Sanofi Group (Cambridge, MA)
- …in ensuring appropriate review and approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial ... **Job title:** US Medical, Head of Oncology, North America Specialty Care **Location**...and you'll provide inspirational leadership to the Oncology Medical Affairs teams to assure delivery of key strategies and… more
- Rhythm Pharmaceuticals (Boston, MA)
- …for the Clinical Quality Assurance organization. This role reports into the SVP, Global Regulatory Affairs and GCP/GLP QA. Responsibilities and Duties ... improvement. + Collaborate with cross-functional teams, including clinical operations, regulatory affairs , pharmacovigilance, and other relevant departments, to… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs TAU colleagues and Global Regulatory Project Management and Strategic Planning (RPM&SP) head . Identify and propose solutions ... Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the … more
- Takeda Pharmaceuticals (Boston, MA)
- …deliver your best. As part of the US Oncology Marketing, you will report to Head of US Oncology Marketing and work with Sales, Regulatory , Customer Excellence, ... Market Research, Commercial Operations, Legal, Patient Advocacy, Medical Affairs , Payer, Value and Access, Strategic engagement leads and Patient marketing. **How… more
- Sanofi Group (Cambridge, MA)
- …of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully ... and externally as "one GRA voice" with TA, GBU Head and up to the GRA LT when needed...in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ **Essential** + Degree in in a technically relevant field (eg, Regulatory Affairs , Engineering, Information Technology, Computer Science, Health Economics, ... globally. You will also ensure compliance with local and global regulations and standards, staying informed about regulatory...required; + Minimum of 3-5 years of experience in regulatory affairs , compliance, or a related field… more
- Sanofi Group (Cambridge, MA)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...Groups, Chief Scientific Officer, etc. + Collaborate with the Global Head by providing scientific guidance and… more
- Takeda Pharmaceuticals (Boston, MA)
- …the best of my knowledge. **Job Description** **Objectives:** + Work with the Global Medical Unit Head (GMUH), medical functional leads, immunology leadership, ... global brand strategy, incorporating cross-functional strategies (eg Commercial, Regulatory , and Region/country medical partners, and others, as appropriate). +… 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 ... Global Medical Director of Dermatology, reports to the Global Medical Head of Immunology and works...preferred. + Experience in pipeline, clinical development and/or medical affairs on a global or regional level… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …patient access programs and initiatives across the organization. You will report to the Head of Patient Access, Global Medical **How you will contribute:** + ... to expanded access programs to cross-functional teams + Collaborates with cross-functional, global and local teams (eg Medical affairs , Clinical supplies R&D)… more
- Pfizer (Cambridge, MA)
- …publications. + Provide input into the regulatory strategy and interact with Regulatory Affairs and regulatory agencies as appropriate. + Provide ... and to propose new concepts and ideas in drug development. + Knowledge of global regulatory /industry rules and guidance. + Ability to synthesize medical and… more
- Pfizer (Cambridge, MA)
- …Management, CMAO, Medical Affairs Strategy, Biostatistics & Data Management, Global Regulatory Affairs , Clinical Pharmacology / Pharmacometrics, Market ... **ROLE SUMMARY** **The Platform:** The Chief Medical Affairs Office's Real World Evidence (RWE) Platform is...Real World Evidence (RWE) Platform is responsible for establishing global scientific leadership and stature through the generation of… 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 leadership ... outcomes research, RW-relevant health informatics, and biostatistics talent from global , international markets into one team to drive efficiency through… more
- Takeda Pharmaceuticals (Boston, MA)
- … Affairs CMC team, you will report to the Executive Director and Head , CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + ... GRA CMC regulatory team in the development and implementation of global CMC regulatory strategies during development ,commercialization and post approval LCM… more
- Takeda Pharmaceuticals (Boston, MA)
- …with global cross-functional input (Patient value and Access, Medical Affairs , HEOR, Competitive Intelligence), including a global commercial assessment of ... empowered to deliver your best. As part of the Global Oncology Products, Pipeline and Strategy team, you will...Pipeline and Strategy team, you will report to the Head of New Product Planning and Business Development Search… more