Lead, Us Labeling Operations
CurrentManages the US labeling operations team at BMS. The team:• Supports initial NDA/BLA submissions and subsequent product launches.• Ensures editorial integrity of all labeling (Word files, SPL, artwork) for submission to FDA via eCTD.• Create and update structured product labeling (SPL).• Initiates creation and revision of printed packaging components as regulatory SMEs. • Manages CCDS quality reviews and routing.• Assigns NDCs and manages drug product listings for all marketed packaging configurations, including kits.Strong knowledge of RIMS (Veeva Vault), electronic document (CARA) and artwork management (Esko) systems, proofreading software (TVT, GlobalVision), MS Office and Adobe applications.