Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds.
Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents.
Contribute to and participate in 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.
Requirements:
Minimum of 6 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).
An understanding of pharmaceutical drug development.
Experience in discussing and communicating scientific concepts.
Understanding of worldwide regulatory guidelines and their applications for guidance for labeling.
Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision.
