- Lilly (Indianapolis, IN)
- …of regulatory projects for gene therapy platforms. Draft and review regulatory applications, supplements, amendments, and variations. Communicate regulatory ... New Drug Applications; 5 years of experience with Electronic Common Technical Document elements, structure, and writing; and 5 years of experience with navigating… more
- Lilly (IN)
- …revise and train CCS team on site documents (eg, operational manual, FAQ document , etc.) + Influence vendors to develop strong partnerships wit Investigators, and ... ensuring solutions meet regulatory and ICH/GCP requirements. + Handles ethics review board interactions; interacts with auditors; supports inspections; creates and… more
- Lilly (Lebanon, IN)
- …revision of standard operating procedures and batch records as required. Review technical reports. Conduct deviation investigations and write process deviation ... reports. + Document and appropriately communicate all aspects of work and...Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization… more
- Lilly (Indianapolis, IN)
- …but not limited to: operational readiness, C&Q support, on-floor process support, document reviews, change controls. + Support the roll out of process safety ... program elements such as employee participation, Management of Change, Pre-Startup Safety Review , Process hazard analysis (PHA), etc. + Support the Site PSM Team… more
- Lilly (Indianapolis, IN)
- …developing trial documents, procedures, and plans + Support authorship and review of clinical/regulatory documents ( _e.g_ ., clinical protocols, Investigator ... ability to express oneself clearly and concisely, and to message and document key progress and challenges appropriately; excellent presentation skills required +… more
- Lilly (Indianapolis, IN)
- …OEM, site Automation, Lilly IT and Lilly Telecom as needed. + Perform review vendor internal documentation and testing, perform code/design compares, document ... Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of… more