San Diego, CA30+ days ago
This role will work collaboratively across various functions including Regulatory Affairs, Clinical Development, CMC, Clinical Pharmacology, Clinical Supply (CS), Medical Affairs/Medical Information, Medical Writing, Pharmacovigilance, Quality Assurance (QA), and legal as well as external vendors (as required) to ensure appropriate content and quality control checks are proceduralized and implemented for all labeling activities including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), Instructions for use (IFUs), medication guides, annotated labels and their associated Patient Labeling Documents to support initial Marketing Authorization and lifecycle updates (e.g., new indications, efficacy data, product quality change Responsibilities: Direct and ensure effective execution of optimal strategies for labeling development by providing global labeling insight, developing and implementing harmonized labeling processes for new product labels and associated life-cycle activities, and tracking/maintaining labeling documents. In this role, the Senior Director role requires a solid understanding of global labeling requirements, labeling platforms, label tracking, change control, and print production processes to effectively manage end-to-end label creation and implementation.