- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Merck & Co. (Boston, MA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be… more
- CSL Behring (Waltham, MA)
- …and protect CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director , Corporate & External Affairs , R&D ... **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager,...Portfolio **Main Responsibilities and Accountabilities:** + Support the Associate Director in serving as a business… more
- Sanofi Group (Framingham, MA)
- **Job title** : Global Regulatory Affairs Device Lead ( Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical… more
- Sumitomo Pharma (Boston, MA)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) ... medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **Accountabilities:** + The Associate Director will be responsible for complex or highly complex ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …the development of scientific communications strategy and deliverables, the ** Associate Director , Scientific Communications Lead, Hematology** proactively ... deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific...in life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead, develops and… more
- Takeda Pharmaceuticals (Boston, MA)
- …transformative medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will ... be part of the global regulatory team. As Associate Director ,...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director , Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a champion of Otsuka's culture ... statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Marketing - Care Pathway Education T1D **Location:** Remote/Field **About the Job** The Associate Director , Marketing ... and education across endocrinology, primary care, and health system settings. The Associate Director will translate brand vision into scalable field enablement… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director , R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model ... to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs , the vision is to cover all R&D HCP engagement over time. This… more
- Takeda Pharmaceuticals (Boston, MA)
- …Japan Payer Marketing and Market Access, Global Evidence and Outcomes, Medica Affairs , Clinical Development, Regulatory Affairs , Biostatistics, Global ... leadership at LOC level Decision-making and Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …remotely from a New England state (ME, VT, NH, MA, CT, RI).** The Associate Director , Office for Human Research Studies (OHRS), oversees operational activities ... degree required; degree in Public Health, Life Sciences, Health/Research Administration, Regulatory Affairs , Bioethics, Health Law, or related field preferred.… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview We are seeking an experienced Associate Director , Scientific Communications as part of the North America ... Medical Affairs team to lead the strategic planning and execution...North America Medical team, reporting to the Senior Medical Director , North America, you will be accountable for advancing… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's… more
