- 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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Director , Strategic Planning & Operations is a pivotal role within the Medical Excellence & Operations team within Global Medical Affairs . This role is ... the asset lifecycle. This role reports directly into the Executive Director , Medical Excellence and Operations. **Job Description** **Key Responsibilities Include:**… 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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- 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
- 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
- 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
- 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)
- …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
- 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
- Lilly (Indianapolis, IN)
- …the world. The Associate QA-IDM (Auditor) will report to the Quality Associate Director and will have responsibility for assessing PDS functional areas, ... -Teamwork and interpersonal skills -5 years' experience in Quality and/or Regulatory Affairs Additional Preferences: -Auditor certification (ASQ CQA) and/or… 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