Manager, Global Labeling Product Leader

h3Company Overview /h3 /brpAt Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p /brh3Job Details /h3 /brpJob Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium, Warsaw, Masovian, Poland /p /brpJob Description: Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States
- Requisition Number: R
- Belgium and Poland
- Requisition Number: R
- Switzerland
- Requisition Number: R
- United Kingdom
- Requisition Number: R
- Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. /p /brh3About Innovative Medicine /h3 /brpOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at /p /brpWe are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Beerse, Belgium or Warsaw, Poland. /p /brh3Purpose /h3 /brpGlobal Labeling (GL) is a function within Global Regulatory Affairs accountable for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates. The scope of Global Labeling covers the end-to-end labeling process throughout the product’s lifecycle— from target labeling through the Company Core Data Sheet (CCDS): Primary labeling documents (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI)) Derived labeling documents Our Vision and Mission articulate Global Labeling’s commitment to providing high‑quality, compliant, and timely labeling that supports our stakeholders and patients worldwide. /p /brh3Responsibilities /h3 /brul /brliLeading the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds. /li /brliMaking recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity. /li /brliCoordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. /li /brliEnsure high quality and compliant labeling documents. /li /brliContributing to and participate in 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. /li /brliContributing to the continuous improvement of the end-to-end labeling process. /li /br /ul /brh3Qualifications / Requirements /h3 /brul /brliA minimum of Bachelor’s degree in a scientific discipline is required. /li /brliAn advanced degree (MS, PhD, MD or PharmD) is preferred. /li /brliA minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required. /li /brliA minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is preferred. /li /brliAn understanding of pharmaceutical drug development is required. /li /brliExperience in discussing and communicating scientific concepts is required. /li /brliBasic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required. /li /brliExperience leading project teams within a matrix environment, combined with the ability to work larg