- Lilly (Indianapolis, IN)
- …or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance, regulatory affairs ). + OR + BS degree (or equivalent experience) ... experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance, regulatory affairs ). + Experience in the drug development process… 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 ... and Company is seeking an experienced and highly motivated Associate Director to join our Technical Services/Manufacturing Science (TS/MS) team, specializing in… more
- Lilly (Lebanon, IN)
- …+ Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs + Proficient in statistical analysis and computer ... startup into GMP manufacturing operations. **Position Overview** The Sr. Director - QA serves as the Site Quality Leader...+ Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. + Lead the API Quality Team and… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Role Overview** The Sr. Director , Clinical Development is an experienced clinical trialist who will be responsible ... into clinical development programs both externally and internally (eg, Medical Affairs , Commercial, CROs, etc.). They will provide clinical / scientific support… more
- Lilly (Indianapolis, IN)
- …Process Development, Engineering, Analytical, Quality, Supply Chain and Raw Materials, and Regulatory Affairs . + Represent the PTE team during regulatory ... + Extensive knowledge of cGMP regulations, quality systems, and regulatory requirements related to pharmaceutical API/DS manufacturing and tech transfer.… more
- Lilly (Indianapolis, IN)
- …teams, including medicinal chemistry/genetic medicines/bioproducts, toxicology/ADME, bioinformatics, and regulatory affairs , to integrate data and drive ... opinion leaders, and potential partners. + Contribute pharmacology data to regulatory filings, including Investigational New Drug (IND) submissions. + Support… more
- Lilly (Indianapolis, IN)
- …"patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for ... discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs , medical affairs ) Other… more
- Sumitomo Pharma (Indianapolis, IN)
- …ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + ... (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable functions follow… more