Director, Global Labeling Strategy

Job description

Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), Target Product Label, USPI and local labeling from early-stage development through to product maintenance. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional labeling sub team through discussion and decisions. Evaluate and communicate strategies and anticipate risks associated with CCDS content updates and implementation. Key role of providing labeling leadership, mentoring peers, driving strategic label development and execution of core labeling information. Job Description: - Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide. - Leads or contributes to cross functional teams: Labeling Committees, Labeling Teams, and provide direction and support to Product Review Council teams, Legal and other groups, as needed. - Develop and maintain Target Product Label, Company Core Data Sheet (CCDS) and local labels. - Ensure that all labeling (for development and marketed products) is appropriately developed...