Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents)
Job Summary
Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents).
Contribute to the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.
Contribute to the continuous improvement of the end-to-end labeling process.
Matching Summary
Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents).
Skills & Requirements
Must-have
Global labeling strategy
Primary labeling development
Lead project teams
Document management systems
Scientific concepts communication
Nice-to-have
Customer-focused learning culture
Continuous improvement participation
Competitor analysis
Negotiation and partnering skills
Key Requirements
Bachelor’s degree in a scientific discipline
4 years of relevant pharmaceutical industry experience
3 years of Regulatory Affairs experience in product labeling
Understanding of pharmaceutical drug development
Experience leading project teams in a matrix environment