- Regeneron Pharmaceuticals (Cambridge, MA)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus on ... Clinical Regulatory filings and provide regulatory leadership on...to ensure attainment of governmental approvals. + Responsible for quality and timeliness of IND/CTA and BLA submissions. Interact… more
- Boston University (Boston, MA)
- As a pivotal leader within the Division of Student Affairs , the Director of Residence Life reports to the Senior Associate Dean of Students and oversees a large ... and multifaceted residential program. The Director provides strategic vision, leadership, and management to foster...Life program that aligns with the Division of Student Affairs ' mission, values, and strategic priorities. Ensure that all… more
- AbbVie (Cambridge, MA)
- …and scientific strategic and operational input into core medical affairs activities such as: healthcare professional/provider interactions (HCPs, Patients and ... activities (promotional material generation/product launches) and market access. Drives Medical Affairs input into and influences the development of asset strategy.… more
- Philips (Cambridge, MA)
- …clinical study approvals and review of clinical study protocols. + Reporting to the Director of Regulatory Affairs -Ultrasound, you will partner with ... The Principal Regulatory Affairs Specialist will play a...mentor/coach Philips regulatory professionals; drive improvement in regulatory aspects of the Quality Management System,… more
- Philips (Cambridge, MA)
- **Senior Director of Clinical Affairs ** Delivers clinical knowledge, experience and expertise across the whole value chain from ideation to end-of-life. Focus in ... topics to support strategy development and strategy execution. + Build Clinical Affairs , Market Access and outcomes research capability and governance (together with… more
- Merck (Boston, MA)
- …processes. + Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as ... **Job Description** The Executive Director , Device Quality & Regulatory...and Skills:** + 10+ years of experience in device quality , device regulatory affairs , or… more
- Takeda Pharmaceuticals (Boston, MA)
- …of company Subject Matter Experts across Global R&D (Pharmaceutical Sciences, CMC Regulatory Affairs & Devices), Global Manufacturing Supply and Global ... true to the best of my knowledge. **Job Description** Senior Technical Regulatory Advisor - Pharmaceuticals (Senior/Executive Director ) OBJECTIVES/PURPOSE + To… more
- Takeda Pharmaceuticals (Boston, MA)
- …all applicable laws, regulations, and policies + Interact directly with Clinical, Statistics, Regulatory Affairs , and Medical Affairs to fully understand ... and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group Lead, Solid… more
- Sanofi Group (Cambridge, MA)
- …+ Collaborate with glocal cross-functional teams including Medical TA, Clinical Development, Regulatory Affairs , HEVA, Market Access, and Commercial to align ... **Job Title:** Medical Director - Global Medical Evidence Generation **Location:** Cambridge, MA **About the Job** We are an innovative global healthcare company,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …effectiveness of clinical trial operations. + In close collaboration with Clinical Quality Affairs , develop and maintain Standard Operating Procedures (SOPs), ... entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Director , Clinical Project Management - US reports directly to the Executive … more
- Novo Nordisk (Lexington, MA)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... with, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead where you... regulatory and business issues to ensure the regulatory filings are of high quality and… more
- ICON Clinical Research (Boston, MA)
- …progression through design phases. + Coordinate with cross-functional teams, including R&D, Regulatory Affairs , Quality Assurance, and Manufacturing, to ... Senior Director , Design Control- Cambridge MA- Hybrid ICON plc...medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during… more
- Regeneron Pharmaceuticals (Boston, MA)
- …closely with key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This role leads ... The Senior Medical Director , Clinical Development will play a key role...advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision Medicine,… 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 the Job**...of science to improve people's lives", Specialty Care Medical Affairs has a vision to be the leaders in… more
- Organon & Co. (Boston, MA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... are sound, based on the most up-to-date literature and regulatory guidances and support the approved early development plans....while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the… more
- Takeda Pharmaceuticals (Boston, MA)
- …+ Interacts with and influences other cross-functional departments (eg Development Operations, Regulatory Affairs , Medical Affairs , Data Science Institute, ... oversight of safety-related activities performed by partners and CROs specifically for quality and performance. + Anticipates regulatory implications of emerging… more