- Lilly (Indianapolis, IN)
- …manufacturing and initial validations with API EM and CMs. The Sr . Director TS/MS is responsible for leading scientists involved in technical aspects of ... Development, or Administration is desirable. Additional Information: + Must complete ITP for Sr Director TS/MS. + No certifications required. + Tasks require… more
- Lilly (Indianapolis, IN)
- …manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will serve as Manufacturing TSMS senior representative to work ... comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in… more
- Lilly (Indianapolis, IN)
- …comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in ... strategies and manufacturing focused scientific capability. The Central API TSMS Director /Executive Director will provide technical and scientific expertise… more
- Lilly (Indianapolis, IN)
- …better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory Lead ... Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists ) and is responsible for forming and maintaining a… more
- Lilly (Indianapolis, IN)
- …of study conduct at the TPO via communication with the Study Director and/or onsite observation, and real time communication with the Toxicology ADME/ToxPath/Drug ... Development:** + Partner with Toxicology Project Leaders and other scientists to develop study designs and detailed study protocols,...comments and assure they are conveyed to the Study Director at the TPO **Business Plan Objectives:** + Lead… more
- Lilly (Indianapolis, IN)
- …validations, and process optimization for the peptide portfolio, including Mounjaro. The Sr Director leads technical aspects of drug substance manufacturing ... a diverse portfolio of drug substances essential to Lilly! The Central API TS/MS Sr . Director will provide technical and scientific expertise within a dynamic… more
- Lilly (IN)
- …reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; the outreach medical activities aimed at ... in support of demand realization. In addition, with input from the Director -Medical and Business Unit Team Physician/Regional Medical Leader, the CRP is responsible… more
- Lilly (Indianapolis, IN)
- …Statisticians + Scientific communication associates + Health outcomes research consultants/research scientists + Regulatory directors, scientists , and ... additional items including but not limited to protocols, publications, regulatory interactions, internal executive and governance presentations, external key opinion… more
- Lilly (Indianapolis, IN)
- …external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and ... SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. + Ensure control… more
- Lilly (Indianapolis, IN)
- …clinical experience, the Diabetes and Obesity Business Unit - Global Medical Affairs Senior /Executive Director is an integral member of the medical affairs team ... definition of "customer" here includes patients, providers (HCPs) and payers. The Senior /Executive Director may also work closely with global Development teams,… more