- Sumitomo Pharma (Indianapolis, IN)
- …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 (Indianapolis, IN)
- …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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- 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. (Indianapolis, IN)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and ... patient outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) API External Manufacturing is ... of Quality projects, technology transfers, and commercialization. The API EM QA Associate Director is responsible for quality projects supporting API EM,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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. (Indianapolis, IN)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP quality ... alignment with corporate quality objectives + Cross-functional Leadership:Collaborate with Regulatory Affairs , Technical Operations, Manufacturing, and Supply… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- ** 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
- Lilly (Indianapolis, IN)
- …world. Eli Lilly and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, ... processes and product quality. * Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs , and Supply Chain teams to ensure seamless… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Position Summary:** **The Associate Director - Global Quality Management Review Lead will drive the ... as a strategic liaison between Global Quality and business units (eg, regulatory affairs , manufacturing, IT) to ensure metric relevance and adoption.**… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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
- Lilly (Indianapolis, IN)
- …functional teams including Case Management and Clinical Operations, Commercial teams, Medical Affairs , and Regulatory functions to ensure seamless integration of ... life better for people around the world. **Job Responsibilities:** The Sr. Director PV Case Management ICSR provides technical leadership for the design,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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
- Sumitomo Pharma (Indianapolis, IN)
- …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