Location: Raritan,NJ, USA
Johnson & Johnson Innovative Medicine is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland). Remote work options may be considered, on a case-by-case basis and if approved by the Company.
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Key Responsibilities:
* 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.