- GRAIL (Washington, DC)
- …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
- Sumitomo Pharma (Washington, DC)
- …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
- Humana (Washington, DC)
- …of our caring community and help us put health first** The role of Director , Federal Government Affairs involves direct engagement with Senate, House, and/or ... years of professional experience in Senate, House, Administration, government affairs , campaign, health policy and/or advocacy roles. Positions within committee,… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- 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
- United Therapeutics (Annapolis, MD)
- …that UT data is approved and ready for field use following presentation. Associate Medical Excellence & Training Director Minimum Requirements + Bachelor's ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- 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. (Washington, DC)
- …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. (Washington, DC)
- **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
- Guidehouse (Mclean, VA)
- …Software, Assay chemistry, microbiology, virology, immunology **_Programmatic/Technical Advisor_** - Associate Director + **Doctoral degree** in biological ... FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- **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. (Washington, DC)
- 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
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …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. (Washington, DC)
- …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
- University of Washington (Annapolis, MD)
- …positive outlook and calm demeanor, and to work independently, especially during times when the Director and Associate Director are away from the office for ... **Job Description** **We have an outstanding opportunity for an Assistant to the Director to serve as the first point-of-contact in the DC-based Office of Federal… more
- Otsuka America Pharmaceutical Inc. (Washington, DC)
- …internal and external regulations. This position reports directly to the Associate Director , CNS Scientific Communications. **Job Description** **Key ... Include:** **Core Content Development** + Under the guidance of the Associate Director , Medical Communications, draft and maintain high-priority, foundational… more
- Amgen (Washington, DC)
- …within Amgen and collaboratively across both companies. This role reports to the Director , Advocacy Relations, Inflammation and Bone Business Unit, will be based in ... including those focused on education and access. + Partner closely with Medical Affairs , Commercial, Access, Corporate Affairs , Government Affairs , and… more
- Sumitomo Pharma (Washington, DC)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable ... system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as… more
