- 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
- Rhythm Pharmaceuticals (Boston, MA)
- …to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be ... and life cycle of Rhythm products. This role reports into the Director , Global Regulatory Affairs . Responsibilities and Duties + Act as the Global… more
- Takeda Pharmaceuticals (Boston, MA)
- …order to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs , Neuroscience is responsible for ... regulatory strategy. + Participates in cross-functionalinitiativeswithin Global Regulatory Affairs and Takeda R&D. **How you...and Takeda R&D. **How you will contribute:** + The Associate Director will be responsible for increasingly… more
- Takeda Pharmaceuticals (Boston, 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)
- …to the best of my knowledge. **Job Description** **Job Title:** Associate Director - Analytics, Global Regulatory Affairs **Role Purpose:** Strategic and ... operational oversight of custom analytics deliveries from Global Regulatory Affairs involving Business Intelligence solutions and related semantic layer… more
- United Therapeutics (Boston, MA)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary:** The Associate Director of Global Medical Affairs Omnichannel will be responsible for developing and leading the omnichannel strategy ... for Global Medical Affairs across all therapeutic areas and brands. This strategic...all omnichannel activities adhere to internal medical, legal, and regulatory standards. + Collaborate with Compliance and Legal to… 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)
- … Information Management (RIM) / Regulatory Operations **Position Summary** The Associate Director , Process Business Analyst & Documentation will serve as a ... is true to the best of my knowledge. **Job Description** **Job Title:** Associate Director , Process Business Analyst & Documentation - Veeva Vault RIM… 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
- Humana (Boston, MA)
- …as to officials and staff in regulatory and other agencies. The Director , State Affairs requires an in-depth understanding of how organization capabilities ... , State Affairs represents the organization's position on legislation and/or regulatory affairs to elected representatives and their staff, as well… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality 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
- Takeda Pharmaceuticals (Boston, MA)
- …DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), ... Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization and… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ensuring ... for clinical deviation management, and Serious Breaches investigation and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more
- Takeda Pharmaceuticals (Boston, MA)
- …processes and training and ensure alignment with global processes and regulatory requirements and expectations. + Drive the implementation and change management ... enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements. + Create and deliver training solutions to support the… more
- Grifols Shared Services North America, Inc (Boston, MA)
- …for the therapeutic area(s). + Partners with the Medical Directors, National MSL Sr Director , and North America Medical Affairs Sr Director to develop ... and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a...of field medical plans, strategy, and activities within Medical Affairs , as aligned with goals and objectives. This position… more
