Global Labeling Product Leader - Regulatory Strategy

Johnson & Johnson Co.; Raritan (NJ); Hybride; USD 117 000 - 201 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Paid time off

Parental Leave

Résumé du poste

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader based in Raritan, NJ; Titusville, NJ; or Horsham, PA. You will lead primary labeling and derived labeling documents across compounds, ensuring quality, compliance, and timely updates.

You will guide content, processes, and timelines, participate in global labeling strategy, and drive continuous process improvements within a matrix organization.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Advanced degree (MS, PhD, MD or PharmD) preferred.
• 4+ years in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) required.

Responsabilités

• Lead development, revision, review, and maintenance of primary labeling (CCDS, USPI, patient labeling) and derived documents for assigned compounds.
• Provide guidance on labeling content, processes, and timelines; resolve labeling issues with impact on labeling and documentation.
• Contribute to global labeling strategy and understand competitors’ development plans and labeling approaches.
• Support continuous improvement of end-to-end labeling processes.

Connaissances

Regulatory leadership

Project management

Analytical thinking

Communication

Cross-functional collaboration

Business writing

Formation

Bachelor’s degree in science

Advanced degree preferred

Outils

Document management systems

Regulatory submissions tools

Description du poste

Johnson & Johnson is seeking a Manager, Global Labeling Product Leader based in Raritan, NJ; Titusville, NJ; or Horsham, PA. You will lead primary labeling and derived labeling documents across compounds, ensuring quality, compliance, and timely updates.

You will guide content, processes, and timelines, participate in global labeling strategy, and drive continuous process improvements within a matrix organization.