- Rhythm Pharmaceuticals (Boston, MA)
- …learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be responsible for ... cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities...Regulatory Agency requests + May serve as the liaison between the company and Regulatory Agencies… more
- Takeda Pharmaceuticals (Boston, MA)
- …global vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges that… more
- Lilly (Springfield, MA)
- …to make life better for people around the world. **Purpose:** The Health Outcomes Liaison (HOL) team serves as the medical and health economic and outcomes research ... + Stay abreast of emerging science, environmental trends, healthcare policy, and regulatory actions relevant to US population-based decision-makers + Serve as a… more
- Takeda Pharmaceuticals (Lexington, MA)
- …of proposed promotional and disease state materials. + Collaborate with Regulatory Affairs , Medical, Legal, Commercial, and Compliance, execute and ... to the best of my knowledge. **Job Description** **Associate Director , US Advertising & Promotion Regulatory Review**... regulatory requirements. + Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Sanofi Group (Cambridge, MA)
- …Ready to get started? **Main Responsibilities** + In conjunction with the Global Regulatory Affairs Head of Global Advertising & Promotion, recommend and ... **Job Title** : Senior Director , Global Regulatory Advertising and Promotion...assigned. **About You** **Experience** + Successful track record in Regulatory Affairs with 7 -10+ years of… more
- Takeda Pharmaceuticals (Boston, MA)
- … liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and ... interactions/meetings related to assigned programs and supports regional and local regulatory affairs teams with health authority interactions. + Ensures… more
- State of Massachusetts (Boston, MA)
- …intended to streamline the permitting and approval process for development projects. The Director of the Permit Regulatory Office will be the point of ... state agencies that issue project permits and approvals. This position will serve as director of the permit regulatory office established within EOED by section… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** US Medical Science Liaison , AIR -- NextGen Immunology-NYC, LI **Location:** NYC, Long Island, NY **About the Job** This position will report into the ... Immunology team which is a segment of the Medical Affairs Specialty Care organization. Our Medical Affairs ...serves as a valued strategic partner with Clinical, Commercial, Regulatory , and Market Access on therapeutic solutions to support… more
- Novo Nordisk (Lexington, MA)
- …the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal and ... make a difference? The Position The Senior International Medical Director serves as a subject matter expert for our...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**Job Description** **OBJECTIVES:** + Collaboration with functional Medical Affairs partners (including Global Medical Leads, Scientific Communications, Evidence ... Generation and LOC Medical Affairs ), responsible for leading the ITP and IgAN Training...required + Experience in customer-facing roles (eg Medical Science Liaison , Product Specialist) is preferred + 2+ years of… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** Reporting to the US Specialty Care Medical Affairs (US SCMA) Lead for Gastroenterology, Biosimilars, and Rheumatology within headquarters, the ... Senior Director , Rheumatology will be an integral member of the...ideas, and needs + Collaborate with other regional Medical Affairs teams, Marketing/Commercial team(s), relevant Pfizer research groups, and… more
- Novo Nordisk (Lexington, MA)
- …Nordisk US Clinical Development Group, whose functions include Drug Safety, Regulatory Affairs , Clinical Operations, Medical Writing, Biostatistics, Data ... excellent medical support to development programs at all stages + Provide support to Regulatory Affairs team members in the compilation of regulatory … more
- Bristol Myers Squibb (Cambridge, MA)
- …(Masters, PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** ... in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** The… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing. + ... **Job Title** : Clinical Research Director **Location:** Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to speed up… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug discovery, drug safety, marketing + ... what you thought was possible. Ready to get started? The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency… more
- State of Massachusetts (Boston, MA)
- …Executive Director on all inquiries from the Director of External Affairs and the OCA Legislative Liaison regarding responses to inquiries from the ... Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making...public. The PC III works closely with the Executive Director of the Public Safety Unit to carry out… more
- Baystate Health (Springfield, MA)
- …Analyst is responsible for having the knowledge and ability to conduct regulatory activities pertaining to the review of initial submissions, continuing reviews and ... reporting, actively participate in site visit preparation and actively participate in regulatory audits for FDA, OHRP and AAHRPP accreditation of the Human Research… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …global organizations is required. + Experience in field-based roles (eg Medical Director , Medical Science Liaison ) and/or clinical development is helpful. **Key ... across functions in R&D and Global Portfolio Division (Clinical, Medical, Regulatory , Global Evidence and Outcome (GEO), PV, Global Product Launch Strategy… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …or global organizations is required. + Experience in field-based roles (eg Medical Director , Medical Science Liaison ) and/or clinical development is helpful. + ... functions in R&D and Global Portfolio Division (Clinical, Medical, Regulatory , Global Evidence and Outcome (GEO), PV, Global Product...a matrix or franchise structure. + Experience in medical affairs is required, preferably in GI and IBD. +… more