- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Collaborate cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other ... **Associate Director , Small Molecule Analytical Development** + Lead and...the drug development lifecycle, including preclinical and clinical stages, regulatory requirements, and quality standards. **Competencies** **Accountability… more
- Rhythm Pharmaceuticals (Boston, MA)
- …collaboratively with key inter-disciplinary stakeholders (eg biostatistics, clinical development and regulatory affairs ) to drive the generation of actionable ... outputs into actionable insights to inform publications, protocol development, and regulatory submissions. + Ensure data quality , reproducibility, and compliance… more
- Bristol Myers Squibb (Cambridge, MA)
- …and rapid, data-driven decision making; and (iii) ensuring that only high quality and differentiated assets enter the market. Key Responsibilities Strategy and ... late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision… more
- CVS Health (Boston, MA)
- …of the training application system.** **Working across lines of business, the Director will align and work with senior leaders to provide consistent guidance ... used to support our customer vision and leadership in healthcare. The Director will provide leadership direction, define project scope, identify scalable solutions,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Strong cross-functional collaboration experience, including working with Legal, Compliance, Regulatory , Medical Affairs , and Clinical Operations. + Familiarity ... while also establishing and refining the infrastructure needed to enable consistent, high- quality evidence planning across the organization. This role is pivotal in… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... strategy for and lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Medical Director Hemophilia **Location:** Cambridge, MA / Morristown, NJ **About the job** The role reports to the Global Head of Hemophilia ... insight gathering activities (eg, advisory boards) as defined in the medical affairs plan. + Review externally facing promotional and medical materials. **About… more
- Sanofi Group (Cambridge, MA)
- …cross-functional teams, including Market Access Shared Services, Brand Strategy, Medical Affairs , Regulatory , Patient Support Services, distribution and Finance, ... **Job Title:** Country Market Access and Pricing Senior Director , Access Strategy Amlitelimab **Location:** Cambridge, MA or Morristown, NJ **About the Job** The Sr.… more
- Takeda Pharmaceuticals (Boston, MA)
- …with the ability to make tough talent decisions. + Deep expertise in ** Regulatory Affairs , Clinical Development, and R&D technology ecosystems** (eg, Veeva Vault ... to track value delivery.** **_ACCOUNTABILITIES:_** + **Drive platform rationalization, data quality , and master data management strategies across Regulatory and… more
- Takeda Pharmaceuticals (Boston, MA)
- …with: + Pharmaceutical Sciences. + Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda ... **Location: Cambridge, MA** **About the role:** As a Process Scientist (Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), you will provide… more