- Lilly (Lebanon, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... necessary but also incorporating external experiences and learning. + Ensure regulatory compliance and operational excellence by supporting lean principles.… more
- Lilly (Indianapolis, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... Steward for IAPI Drug Substance and ensure alignment with global decisions and practices. + Ensure the analytical control...as needed. + Advise on the analytical component of regulatory strategies for specific molecules. + Author and review… more
- Lilly (Lebanon, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards… more
- Lilly (Lebanon, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards… more
- Lilly (Indianapolis, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... portfolio as appropriate to meet the growing needs of novel drugs and devices. Compliance : + Provide regulatory submission support + Ensure work products are… more
- Amcor (Franklin, IN)
- …leads the development and execution of plant-wide quality systems, ensuring compliance with customer requirements, internal standards, and regulatory ... is a global leader in packaging solutions for consumer and healthcare products. With industry-leading innovation capabilities, global scale and technical… more
- Sumitomo Pharma (Indianapolis, IN)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations...+ Ability to generate documents / files required for regulatory filing. Ex. Reviewers' Guides, Define.XML, Annotated CRFs etc.… more
- Lilly (IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... clarity. Where applicable the CRL may also represent Investigator Engagement with Regulatory and External Bodies and help shape the country-level clinical trial… more
- Lilly (IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... consultative support to product teams, internal Lilly partners, external organizations, regulatory agencies and external partners on medical and scientific issues.… more
- Lilly (Indianapolis, IN)
- …discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the ... in accordance with the validated process and are compliant to cGMPs and regulatory commitments. **Key Objectives/Deliverables:** + Serve as a liaison between CMs and… more