- Fresenius Medical Center (Waltham, MA)
- …with 25% travel **PURPOSE AND SCOPE:** Manages a field team of regulatory compliance employees and provides regulatory expertise through leadership, ... existing trends and new initiatives related to state and federal regulatory activities. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Maintains current/high level… 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
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs ** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Director , US Advertising and Promotion serves as the regulatory lead on Review Committees (RCs) for products in...Rare Blood Disorder and Neurology portfolio. As the RC Regulatory Affairs representative, work with brands on… more
- Merck (Boston, MA)
- **Job Description** **Global Senior Director of Medical Affairs for Thoracic Malignancies** + The Global Senior Director of Medical Affairs ... edge of therapeutic and patient care advances. + The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset… 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
- Pfizer (Boston, MA)
- …vaccines. **What You Will Achieve** You will represent Pfizer as anApprovalLiaison in the regulatory affairs team. You will play the critical role of providing ... strategic regulatory expertise as Global regulatory representative to Product Team(s). As a Director...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… 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
- Merck (Boston, MA)
- …execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating ... **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
- Sanofi Group (Cambridge, MA)
- …accelerate progress. Join our Specialty Care Medical Affairs team as the Senior Global Medical Director , Asthma and you'll provide impactful medical strategy ... **Job title:** Senior Global Medical Director COPD (Dupilumab)...of science to improve people's lives", Specialty Care Medical Affairs have a vision to be the leaders in… more
- Novo Nordisk (Lexington, MA)
- …lives for a living. Are you ready to make a difference? The Position The Senior Director can be accountable for the Clinical pharmacology strategy for phase 1-4 ... Will interact with Medical Specialists, Clinical Operations, Medical writing, Regulatory , Data Science (statistics, pharmacometrics), Research and Early Development,… 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 Medicare Compliance works directly with the...day compliance activities across the organization. + Serve as Regulatory Affairs and Compliance liaison with key… more
- J&J Family of Companies (Cambridge, MA)
- …quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical supplies unit, medical writing, clinical ... Director , Project Responsible Physician - Neuroscience - 2406186566W...Committee (IDMC) and adjudication meetings as needed. + Assists Regulatory Affairs in determining requirements for any… more
- J&J Family of Companies (Boston, MA)
- …of the Johnson & Johnson Family of Companies, is recruiting for a Director / Senior Director , Clinical Rseearch Physician for **Late Development Oncology** ... partnership with the Compound Development Team (CDTL) and project management, global regulatory affairs , clinical pharmacology, health economics, and the disease… more
- AbbVie (Boston, MA)
- …also collaborates with functions across the organization, including Commercial leadership, Medical Affairs , Regulatory Affairs , Government Affairs , ... growth driver. This newly-created position is responsible for solid tumor corporate affairs strategies supportive of the Oncology Business Unit and as a member… 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
- Sanofi Group (Boston, MA)
- …report into the US Medical Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs function serves as a valued ... strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support patients' needs. The US Medical Immunology team is… more
- Bristol Myers Squibb (Cambridge, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . Title: Executive Director , Multiple Myeloma Disease Head Translational Medicine at BMS ... activities for the pipeline and supports late stage portfolio for regulatory , translational development and life cycle management. The Heme Translational Medicine… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing… more