Manager, Global Labeling Product Leader

About the role

Johnson & Johnson is looking for a Manager, Global Labeling Product Leader to be based in Allschwil, Berne or Zug, Switzerland. The role sits in the Regulatory Affairs group, within Global Labeling, which is responsible for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions and affiliates. It covers the end-to-end labeling process, from target labeling through the Company Core Data Sheet (CCDS), including primary documents such as the CCDS, USPI and patient labeling, and EU Product Information (EUPI).

Key responsibilities

• Lead the development, revision, review, agreement and maintenance of primary labeling (CCDS, USPI, patient labeling, EUPI) and derived labeling documents for assigned compounds.
• Advise on labeling content, processes, timelines and scientific integrity, and coordinate the resolution of labeling issues that could affect primary or derived labeling or its supporting documentation.
• Ensure labeling documents are high quality and compliant.
• Contribute to the global labeling strategy, including understanding competitors' development plans and labeling aspects.
• Contribute to continuous improvement of the end-to-end labeling process.

Required profile

• Bachelor's degree in a scientific discipline; an advanced degree (MS, PhD, MD or PharmD) is preferred.
• Minimum 4 years of relevant experience in the pharmaceutical industry (e.g. Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).
• Minimum 3 years of Regulatory Affairs with product labeling or labeling regulation experience preferred.
• Understanding of pharmaceutical drug development and basic knowledge of worldwide regulatory guidelines for labeling.
• Experience leading project teams in a matrix environment and working largely independently with limited supervision.
• Proactive approach, continuous improvement experience, and strong verbal and written communication, organizational, negotiation and partnering skills.
• Experience with document management systems; a track record of managing multiple products and projects at once is preferred.

Required skills

• Document management systems
• Regulatory affairs and regulatory compliance
• Analytical reasoning, business writing, risk assessments and strategic thinking