Global Labeling Manager – Consultant – NJ
1. Coordinate and lead cross-functional teams in the development and lifetime maintenance of the TPP, CCDS and Country Product Information (CPI) and CPI components for assigned products/projects. This includes QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission. 25%
• Minimum BS degree or higher in Life Sciences
• 5+ years in Regulatory, R&D or related area, at least 3 years of experience in labeling or equivalent experience within the pharmaceutical industry.
• Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling; knowledge of and experience with Asia and Emerging Market labeling desirable.
• Experience in both local and global regulatory labeling environments.
• Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
• Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.