Manager, Global Labeling Product Leader

Johnson & Johnson seeks a Manager, Global Labeling Product Leader to oversee strategic development and lifecycle management of product labeling across therapeutic areas and regions. The role involves leading primary and derived labeling documents, coordinating global labeling strategy, and ensuring regulatory compliance and scientific integrity.

Responsibilities

• Lead development, revision, and maintenance of primary labeling documents including CCDS, USPI, and EUPI
• Provide recommendations and guidance on labeling content, processes, timelines, and scientific integrity
• Coordinate resolution of labeling issues affecting primary or derived documents and supporting documentation
• Contribute to global labeling strategy and competitive analysis within assigned therapeutic areas
• Drive continuous improvement of end-to-end labeling processes

Requirements

• Bachelor's degree in scientific discipline; advanced degree (MS, PhD, MD, PharmD) preferred
• Minimum 4 years pharmaceutical industry experience in regulatory affairs, clinical, medical information, or pharmacovigilance
• Minimum 3 years regulatory affairs experience with product labeling and labeling regulations
• Understanding of pharmaceutical drug development and worldwide regulatory guidelines
• Experience leading project teams in matrix environments with independent work capability
• Document management systems experience and demonstrated ability to manage multiple products simultaneously
• Exceptional written and verbal communication, negotiation, and partnering skills