- 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 ... vision, strategy, and delivery of technology solutions that enable global R&D, Regulatory , or Global Development functions. This role owns a portfolio of platforms… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** The Director , HCP Marketing Lead guides the healthcare provider (HCP) engagement strategy for Centanafadine, a novel launch product for ADHD. ... engagement to drive awareness, adoption, and utilization among HCPs. The Director will work cross-functionally with sales, market access, medical affairs… 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
- Takeda Pharmaceuticals (Boston, MA)
- …+ Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs . + SME for Takeda drug product manufacturing organization ... **Location: Cambridge, MA** **About the role:** As a Process Scientist (Associate Director ) - Global Manufacturing Science GMSci Drug Product (DP), you will provide… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . * Advanced knowledge of regulatory ... approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. * Represents Clinical Pharmacology in meetings with global or… more
- Dana-Farber Cancer Institute (Boston, MA)
- …clinical trials start-up, active and close out phases + Proficient knowledge of regulatory affairs , research ethics and the responsible conduct of research + ... submissions and IND management. Reporting to the CTIP Associate Director for Reg unit, the Regulatory Operations...CTIP Associate Director for Reg unit, the Regulatory Operations Manager (ROM) will oversee the CTIP … more
- Pfizer (Cambridge, MA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational oncology, ... clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong… more
- Olympus Corporation of the Americas (Westborough, MA)
- …by applicable federal, state or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA/RA) ... supports business objectives through: proactive monitoring and application of global regulatory requirements within the regional QMS; leading the governance of the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …to address strategic objectives to business partners. + Work closely with medical affairs , marketing, and IT teams to ensure alignment and integration of omnichannel ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency ... external regulations. This position reports directly to the Associate Director , CNS Scientific Communications. **Job Description** **Key Responsibilities Include:**… more