- Lilly (Indianapolis, IN)
- …Case Safety Reports (ICSRs), ensuring the accuracy, integrity, and compliance of global regulatory reports, and for collaborating cross functionally and ... and the Red Book. + Adapt to the changing global regulatory environment. + Perform other duties...in drug discovery or development, eg epidemiology, toxicology, pharmacovigilance, regulatory affairs . OR (BS Degree or equivalent… more
- Lilly (Indianapolis, IN)
- …and overarching compliance. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards ... disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs . **Additional Skills/Preferences:** + Responsible for… more
- Roche (Indianapolis, IN)
- …of the Scientific Strategy Director is done in close collaboration with the global research and development, regulatory affairs and US commercial and ... Join Roche, where every voice matters. **The Position** **Scientific Strategy Director (Cardiometabolism & Neurology)** **The Opportunity:** The Scientific Strategy … more
- Lilly (Indianapolis, IN)
- …processes and product quality. * Collaborate cross-functionally with R&D, Quality, Manufacturing, Regulatory Affairs , and Supply Chain teams to ensure seamless ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Lilly (Lebanon, IN)
- …+ Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs + Proficient in statistical analysis and computer ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...startup into GMP manufacturing operations. **Position Overview** The Sr. Director - QA serves as the Site Quality Leader… more
- Lilly (Indianapolis, IN)
- …with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions. ... better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees...life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will… more
- Lilly (Indianapolis, IN)
- …Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs . + Represent the PTE team during regulatory ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Lilly (Indianapolis, IN)
- …teams, including medicinal chemistry/genetic medicines/bioproducts, toxicology/ADME, bioinformatics, and regulatory affairs , to integrate data and drive ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Sumitomo Pharma (Indianapolis, IN)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable functions… more