Manager, Global Labeling Product Leader

Johnson & Johnson Innovative Medicine

Allschwil, Basel-Country, Switzerland
Hybrid
Global labeling strategy
Labeling content, processes, timelines
Resolution of labeling issues
Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds

Job Summary

  • Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union 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.
  • Contribute to the continuous improvement of the end-to-end labeling process.

Matching Summary

Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.

Skills & Requirements

Must-have

  • Global labeling strategy
  • Labeling content, processes, timelines
  • Resolution of labeling issues
  • High quality and compliant labeling
  • Pharmaceutical drug development understanding
  • Leading project teams in matrix environment

Nice-to-have

  • Customer-focused, learning culture
  • Continuous improvement participation
  • Effective prioritization and management
  • Scientific concepts communication
  • Exceptional verbal and written communication
  • Strong organizational, negotiation, partnering

Key Requirements

  • Bachelor’s degree in scientific discipline
  • 4 years pharmaceutical industry experience
  • 3 years Regulatory Affairs labeling experience preferred
  • Basic understanding of worldwide regulatory guidelines
  • Experience with document management systems

Work Rights

Not specified

Tailored Resume

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