- Medtronic (Boston, MA)
- …need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory team for ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit... staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- Battelle Memorial Institute (MA)
- …common. Healthcare innovation is at the core of what we do. Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization's ... regulatory affairs strategy for our Health Business...senior management. + Interface and coordinate with the regulatory agencies (ie, FDA) on submissions, approvals, external audits,… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- ConvaTec (Lexington, MA)
- …to constantly learn and grow while honing your strategic thinking skills Our successful Director / Senior Manager Medical Affairs will be involved in all ... and generation of publications. You will have close liaison with Clinical Affairs , Global Education, Regulatory , Quality, Marketing & Business Development and… more
- Pfizer (Cambridge, MA)
- Job Description **ROLE SUMMARY** The Senior Medical Director will be responsible for leading several US Medical Affairs activities in support of **Thoracic ... portion of time will be externally facing, and the Senior Medical Director will provide therapeutic area/product...of patients and HCPs. Working closely with Global Medical Affairs and cross-functional colleagues, s/he ensures that the US… more
- Philips (Cambridge, MA)
- …internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with global team ... Recommends strategies for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems and assists… more
- Spectrum (Worcester, MA)
- …constituencies related to our business and services. + In coordination with the Senior Director , ensuring alignment of SGA priorities and community strategies ... level. They are seeking a bright, determined, and committed Director of Government Affairs to join the...overall objectives. You will report directly to the area Director , leveraging your legislative and regulatory experience… more
- Beth Israel Lahey Health (Plymouth, MA)
- …patient population served in the hospital. **Duties/Responsibilities:** Under the guidance of the Senior Director of Quality and Patient Safety, members of ... with disclosure of an event when indicated. + The Director will oversee the Risk Specialists as they lead...conflict resolution * Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred… more
- Harvard University (Cambridge, MA)
- …data, and supporting students through the licensure process. This role reports to the Senior Associate Dean of Academic Affairs and Student Services and is part ... 65265BRAuto req ID:65265BRJob Code:S0558M FSS Academic Affairs Mgt IV Department Office Location:USA - MA - Cambridge Business Title:Associate Director for… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …MDMP interacts and partners with marketed products R&D function leads ( regulatory affairs , pharmacovigilance, global development operations and project ... integrated partnership(s) with R&D functional leads on assigned R&D MPT ( regulatory affairs , pharmacovigilance, global development operations). + Collaborate… more
- J&J Family of Companies (Raynham, MA)
- Senior Director , Orthopedics Epidemiology & Real World Data Science - 2406175060W **Description** The Johnson & Johnson MedTech Epidemiology and Real World Data ... Science team is recruiting for a Senior Director , Orthopedics Epidemiology & Real-World Data...with the Health Economics and Market Access (HEMA), Medical Affairs and Clinical teams to develop the strategic plan… 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 ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Senior Director , GRA Pharmaceuticals- Small Molecule where you will establish… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed + May lead Health Authority… more
- Sanofi Group (Cambridge, MA)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global) especially in ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...regions / GRA-CMC /GRA-Devices to communicate the outcome to senior management as needed + May lead Health Authority… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... staying **True to Life.** **Job Description** Leads and directs regulatory compliance communications to ensure compliance of the Global...areas of compliance risk and present these risks to senior leadership at Olympus in a clear and concise… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** The Senior Medical Director HQ PAXLOVID Team Lead reports to the COVID-19 Medical Lead and is responsible for leading a team of HQ Medical ... Affairs colleagues in providing disease and product expertise for...+ Provides medical support and input on labeling and regulatory interactions + Serve as a Medical resource to… more
- Merck (Boston, MA)
- …monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** Evaluating pre-clinical ... **Job Description** The ** Senior Clinical Director (Sr. Principal Scientist)**...closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage… more
- Harvard University (Cambridge, MA)
- …Manager Department Office Location:USA - MA - Cambridge Business Title: Senior Director of Compliance for Strategic Research InitiativesSub-Unit:Office ... + Thorough understanding of a broad spectrum of the regulatory and policy requirements related to research administration and...the Office of the Vice Provost for Research, the Senior Director of Compliance for Strategic Research… more
- Philips (Cambridge, MA)
- ** Senior Director of Health Economics, Market Access & Reimbursement (HEMAR)** The Monitoring and Connected Care HEMAR leader will provide vision and strategic ... in the global payment systems. + Working with the Director , US Policy, HEOR Team, and HEMAR International Team,...Health Economics and Outcomes Research (HEOR) Team, and Clinical Affairs leaders to influence the short and long-term clinical… more