Associate Director leading global labeling strategy for pharmaceutical products at Johnson & Johnson. Collaborating with regulatory and clinical teams to ensure proper labeling and compliance in key markets.
Responsibilities
Drive the global labeling strategy, including understanding of competitors.
Take leadership role and partner with Global Regulatory Leads (GRLs) and other functional partners.
Lead target labeling development.
Collaborate to provide labeling input relevant to clinical study protocols.
Provide strategic labeling advice for local labeling in major markets.
Analyze relevant competitor labeling and develop labeling strategy and content.
Lead Health Authority (HA) labeling strategy discussions.
Lead the development and revision of labeling documents for assigned compounds.
Represent global labeling in cross-functional teams.
Requirements
A minimum of a Bachelor’s degree in a scientific discipline is required.
Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.
A minimum of 8 years of professional work experience is required.
A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.
Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
An understanding of pharmaceutical drug development is required.
Experience leading project teams in a matrix environment is required.
Experience leading continuous improvement projects is required.
Experience working with document management systems is required.
Must have exceptional verbal and written communication skills.
The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.
Benefits
Inclusive work environment
Opportunities for professional development
Collaborative culture
Health insurance
Job title
Associate Director, Global Labeling Product Leader
Product Manager at Emerson responsible for driving innovation and managing product lifecycle. Collaborate cross - functionally to develop new products and improve existing portfolio in the electrical utility market.
Data Engineering Manager leading analytics team for Ford's data ecosystem. Designing and maintaining data pipelines supporting AI and Software Engineering.
Product Owner managing individual customer payment card offerings in a leading bank in Poland. Collaborating with cross - functional teams to innovate and enhance customer experiences.
Head of Product leading a product roadmap impacting thousands of users daily in a health/fitness startup. Collaborating with a small accomplished team and reporting directly to the CEO.
Director of Product Delivery at RoadSync managing on - time product shipping. Collaborating with cross - functional teams to optimize product launch and operational cadence in the fintech space.
Senior People Technology Specialist advancing global Time Tracking and Absence Management solutions in Workday. Ensuring accurate payroll integration and compliance while collaborating with stakeholders.
Associate Director leading global labeling strategy at Johnson & Johnson, fostering innovations in healthcare. Collaborating on regulatory processes to enhance drug labeling quality.
Business Product Owner managing performance and demand planning for Johnson & Johnson's Innovative Medicine. Collaborating on planning functions to enhance healthcare solutions.
Business Product Owner responsible for performance management, demand planning, and integrated business planning at Johnson & Johnson. Contributing to healthcare innovation and the development of patient - centered solutions.