Overview In this contract role, you will lead global labeling initiatives for Infectious Diseases, Vaccines, and Global Public Health. You will shape the creation and upkeep of core and derived labeling documents, collaborating with cross-functional teams to ensure regulatory alignment and consistency. You'll drive the global labeling strategy and oversee the governance of labeling through LWG and LC processes. You will work closely with stakeholders to disseminate approved labeling deliverables and maintain high-quality standards that support market labeling worldwide. This position offers a strategic opportunity to influence product information and labeling quality at a global scale.
Responsibilities- Create and maintain primary (CCDS, USPI, EUPI) and derived labeling documents and labeling text for packaging components via LWG and LC processes
- Ensure labeling documents meet data alignment, regulatory requirements, and consistency standards
- Contribute to and implement the global labeling strategy and target labeling
- Coordinate development, revision, review, and approval of labeling documents and governance activities with LWG and LC
- Disseminate LC-approved CCDS, USPI, EUPI, and derived labeling documents and supporting materials
- Ensure quality and consistency across labeling deliverables across regions
Key requirements- Executive-level experience in global labeling
- Experience coordinating Labeling Working Group (LWG) and Labeling Committee (LC)
- Knowledge of CCDS, USPI, and EU Product Information (EUPI) labeling formats and requirements
- Attention to detail
- Cross-functional coordination
- Regulatory diligence
- Global labeling process management
- Documentation control and governance
- Regulatory labeling knowledge
