- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Commonwealth Care Alliance (Boston, MA)
- …including budget development, staff resource allocation and shaping the overall Regulatory Affairs Compliance infrastructure. + Promote compliance in CCA's ... **Why This Role is Important to Us:** The Director of Regulatory Compliance works directly...day compliance activities across the organization. + Serve as Regulatory Affairs and Compliance liaison with key… more
- Elevance Health (Boston, MA)
- …+ Requires a BS in Pharmacy or PharmD and ten years of legislative, regulatory , political, public affairs , or industry experience; or any combination of ... **Government Relations Director Sr. - Pharmacy/PBM** **Location:** This position will...effectively communicate and collaborate with government officials, policymakers, and regulatory agencies at the local and State levels in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …program management experienced in leading cross-functional clinical programs within Medical Affairs , Clinical Research, Regulatory , CMC or other drug development ... phases of development with significant experience within related functions (eg, Medical Affairs , Clinical Operations, Regulatory , CMC, Marketing). + Minimum of 5… more
- Pfizer (Cambridge, MA)
- **Change Management Director ** **ROLE SUMMARY** The Change Management Director will report to the Change Management Team Lead within the Operational & Change ... implementation of new ways of working and plans across the Medical Affairs organization, including Global Platforms, Categories, and Regional Medical Leads. The… more
- Sanofi Group (Cambridge, MA)
- …compound, protocol + TA Experts, senior CRDS, global clinical lead, GPHs and medical affairs + CROs + Regulatory affairs + Collaborates with other CRDs ... **Clinical Research Director - allergy-immunology-dermatology** The Clinical Research Director...project clinical sub team, as needed **Responsibilities related to regulatory and safety documents and meetings:** + Review and/or… more