- 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
- 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
- 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
- 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
- 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality operations. +… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global ... outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs , and Technical Operations to ensure supplier… 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
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… 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
- Merck (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
- Boston University (Boston, MA)
- …family members as they apply for immigration benefits. 30% Coordinate with the Associate Director on the development of university policies and procedures ... **ASSISTANT DIRECTOR , STUDENT SERVICES, International Students and Scholars Office**...etc. 5% Plan and direct nonimmigrant outreach services (orientation, regulatory sessions, information sessions, cross-cultural workshops, etc.). Coordinate with… more