Senior Manager, Global Labeling Product Leader (2 Positions)
Location: Raritan, NJ / Titusville, NJ / Horsham, PA
Work Pattern: Hybrid
Company: Johnson & Johnson
Requisition Number: R-007626
Position Summary:
Johnson & Johnson Innovative Medicine R&D is hiring two Senior Managers, Global Labeling Product Leaders. This hybrid role will play a pivotal part in overseeing the development and lifecycle management of primary and derived labeling documents across global markets. The ideal candidate will be a subject matter expert in regulatory labeling content and strategy, ensuring labeling quality and compliance in alignment with global regulations and internal standards.
Key Responsibilities:
Lead development, maintenance, and review of key labeling documents: CCDS, USPI, EUPI, and related patient labeling.
Provide regulatory labeling guidance, ensuring scientific integrity and compliance with global regulations.
Resolve complex labeling issues and ensure timely and accurate updates to documentation.
Contribute to and execute the global labeling strategy for assigned compounds.
Monitor and incorporate competitive intelligence and regulatory developments in labeling practices.
Collaborate cross-functionally and/or with external partners as needed.
Support continuous improvement initiatives across labeling processes.
Required Qualifications:
Bachelor’s degree in a scientific discipline (Advanced degree preferred: MS, PhD, PharmD).
Minimum 8 years of industry experience, including 6+ years in regulatory labeling.
In-depth knowledge of drug development and regulatory affairs processes.
Proven ability to lead matrix teams and projects.
Experience with document management systems and labeling software tools.
Strong organizational, communication, and negotiation skills.
Ability to manage complex labeling portfolios independently.
Preferred Qualifications:
Prior experience in continuous improvement initiatives.
Ability to manage multiple products/projects simultaneously.
Understanding of international regulatory guidelines for product labeling.
Compensation & Benefits:
Salary Range (U.S.): $137,000 – $235,750
Bonus: Eligible for annual performance-based cash bonus
Benefits Include:
Medical, dental, vision, life, and disability insurance
Business accident and group legal insurance
Retirement plans (pension and 401(k))
Long-term incentive program
Paid time off:
Vacation: Up to 120 hours/year
Sick Leave: Up to 40–56 hours/year (location-dependent)
Holiday & Floating Holidays: Up to 13 days/year
Personal & Family Time: Up to 40 hours/year
Equal Opportunity Employer:
Johnson & Johnson is committed to fostering an inclusive workforce. We welcome applications from protected veterans and individuals with disabilities as defined under VEVRAA and Section 503.
Application Deadline: May 22, 2025 (subject to extension)
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