Johnson & Johnson Innovative Medicine · 14 hours ago
Senior Manager, Global Labeling Product Leader
Titusville, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$137K/yr - $236K/yr
8+ years expJohnson & Johnson Innovative Medicine is focused on healthcare innovation to prevent, treat, and cure complex diseases. They are seeking a Senior Manager, Global Labeling Product Leader to manage regulatory affairs activities related to new and modified products, ensuring compliance with regulations and developing high-quality labeling documents.
Pharmaceuticals
Responsibilities
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. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents. This role may collaborate with external partners
Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling
Contribute to the continuous improvement of the end-to-end labeling process
Qualification
Required
A minimum of a Bachelor's degree in a scientific discipline is required
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
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 in discussing and communicating scientific concepts is required
Good understanding of worldwide regulatory guidelines and their application for guidance for labeling 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
Must have strong organizational, negotiation, and partnering skills
Must have the ability to work independently
Preferred
Advanced degree (Master's PhD, PharmD) in a scientific discipline is preferred
Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred
The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred
The ability to drive a collaborative, customer-focused, learning culture is preferred
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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