- Baystate Health (Springfield, MA)
- Under the direction of the Chief Quality Officer, the Senior Director , Regulatory Affairs directs the strategic management and planning for the Joint ... activities for clinical services throughout Baystate Health, including all licensed sites. The Senior Director , Regulatory Affairs develops a… 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
- 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
- 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
- Takeda Pharmaceuticals (Boston, MA)
- …of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs , Pharmaceuticals. **How you ... order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC… more
- Elevance Health (Boston, MA)
- **Government Relations Director Sr . - Pharmacy/PBM** **Location:** This position will work in a hybrid model (virtual and office). The ideal candidate will live ... days in the office per week. The **Government Relations Director Sr .** is responsible for leading advocacy...in Pharmacy or PharmD and ten years of legislative, regulatory , political, public affairs , or industry experience;… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- Ready to help us transform healthcare? Bring your true colors to blue. The Senior Director , Federal Government Affairs will manage BCBSMA activities to ... to the Vice President, State and Federal Government and Regulatory Affairs , and senior leaders...in an integrated and highly effective manner. + The Senior Director , Federal Government Affairs … more
- Orchard Therapeutics (Boston, MA)
- … Affairs Location: United States, ideally Boston or East Coast Job Summary The Senior Director , Medical Affairs will be a leadership role, accountable for ... Medical Affairs strategy, Medical Excellence, and field team execution for Orchard's investigational and approved hematopoietic stem cell - gene therapy (HSC-GT)… 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
- Sanofi Group (Boston, MA)
- …interactions are always within label, and consistent with commercial, compliance, legal and regulatory guidelines. A Sr . TLL will work closely, and within ... initiatives and provide timely feedback. TLLs will report directly to the Director , Dupilumab Dermatology. **JOB RESPONSIBILITIES:** The Sr . TLL job… more
- Commonwealth Care Alliance (Boston, MA)
- **Why This Role is Important to Us:** Under direction of the Sr . Director of Regulatory & External Audits, the primary focus areas of this position includes ... and resulting Corrective Action Plan (CAP). This includes audits from external regulatory agencies including but limited to Centers for Medicare & Medicaid Services… more
- Commonwealth Care Alliance (Boston, MA)
- …Healthcare Compliance (CHC) preferred. + 5 or more years direct work experience in regulatory affairs and/or compliance in Medicare or Medicaid required + 5 or ... Role is Important to Us:** Under direction of the Director of Medicare Compliance, the primary focus areas of...+ Submit materials to regulators + Coordinate attestations from Senior Leadership for submission **Compliance Regulatory Guidance… more
- Commonwealth Care Alliance (Boston, MA)
- …duties as assigned. **Secondary Responsibilities** + Contribute towards the overall Department Regulatory Affairs and Compliance infrastructure at CCA. + Promote ... **Why This Role is Important to Us:** Under direction of the Director of Internal Audit, the primary functions of this position are to: + Contribute towards the… more
- Pfizer (Cambridge, MA)
- …and integrate these insights to co-create and lead a global medical strategy. The Senior Director will: + Be accountable for the development and execution of ... benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead...Director will develop and execute a comprehensive Medical Affairs strategy for Abrocitinib. He/She needs to show a… more
- State of Massachusetts (Boston, MA)
- …**Office of Consumer Affairs and Business Regulation* **Title:** * Senior Director of Programs* **Location:** *Massachusetts-Boston - 501 Boylston ... Call Registry; and Data Breach Notification ("the Programs"). The Senior Director of Programs ("SDP") reports to...to the Programs, and assists the Constituent and Legislative Affairs Director in developing responses to legislators… 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
- Sanofi Group (Cambridge, MA)
- … regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with both ... to have a positive impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director will be a strong subject… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Trainee functioning as a Health System Specialist in the Office of the Director at the Bedford Healthcare System, and is responsible for managing projects and ... program matters under the direction of the Medical Center Director that are delegated to them. You must be...events either separately or in conjunction with the Public Affairs Office. Displays knowledge of Department priorities and mission… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** + Reporting to the VP, Global Gastroenterology Medical Lead, the Senior Director , Gastroenterology (GI) and Biosimilars is an integral member of ... strategic GI medical plan across assets + The Global Senior Director , GI and Biosimilars will...and Country medical teams, Global Clinical Development, Medical information, Regulatory , Safety, etc.) to develop and execute an effective… 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