Manager, Global Labeling Product Leader

Johnson & Johnson•Titusville, NJ

3d•Hybrid

About The Position

Johnson & Johnson’s Global Labeling function within Global Regulatory Affairs is responsible for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates. Its end-to-end scope covers labeling throughout a product’s lifecycle, including target labeling, primary labeling documents—the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, and European Union Product Information (EUPI)—and derived labeling documents. The Global Labeling function is committed to providing high-quality, compliant, and timely labeling that supports stakeholders and patients worldwide. The Manager, Global Labeling Product Leader leads labeling activities for assigned compounds and provides guidance on labeling content, processes, timelines, and scientific integrity. The role contributes to global labeling strategy and continuous improvement of the end-to-end labeling process. The position is based in Raritan or Titusville, New Jersey, or Horsham, Pennsylvania.

Requirements

Bachelor’s degree or higher in a scientific discipline.
At least 4 years of relevant pharmaceutical industry experience, such as Regulatory Affairs, Clinical, Medical Information, or Pharmacovigilance.
Understanding of pharmaceutical drug development.
Experience discussing and communicating scientific concepts.
Basic understanding of worldwide regulatory guidelines and their application to labeling guidance.
Experience leading project teams in a matrix environment and ability to work largely independently with limited supervision.
Proactive approach and experience participating in continuous improvement projects.
Exceptional verbal and written communication, organizational, negotiation, and partnering skills.
Experience working in document management systems.

Nice To Haves

Advanced degree (MS, PhD, MD, or PharmD).
At least 3 years of Regulatory Affairs experience with product labeling or labeling regulations, or equivalent.
Successful track record of effectively and appropriately prioritizing and managing multiple products and projects simultaneously.
Demonstrated ability to drive a collaborative, customer-focused, learning culture.

Responsibilities

Lead the development, revision, review, agreement, and maintenance of primary labeling for assigned compounds, including the CCDS, USPI and associated patient labeling, and EUPI.
Lead the development, revision, review, agreement, and maintenance of derived labeling documents, including labeling text for the EU and US.
Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity.
Coordinate resolution of labeling issues that could affect primary or derived labeling, or supporting documentation.
Ensure labeling documents are high quality and compliant.
Contribute to and participate in global labeling strategy, including understanding competitors in the therapeutic area, their development plans and status, and labeling considerations for developing labeling and target labeling.
Contribute to continuous improvement of the end-to-end labeling process.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
Holiday pay, including floating holidays: 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 a child’s birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.