Manager, Global Labeling Product Leader

pAt 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 . /ph3Job Function: /h3pRegulatory Affairs Group /ph3Job Sub Function: /h3pRegulatory Affairs /ph3Job Category: /h3pProfessional /ph3All Job Posting Locations: /h3pBeerse, Antwerp, Belgium, Warsaw, Masovian, Poland /ph3Job Description: /h3pPlease 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): /ppUnited States
- Requisition Number: R
- /ppBelgium and Poland
- Requisition Number: R
- /ppSwitzerland
- Requisition Number: R
- /ppUnited Kingdom
- Requisition Number: R
- /ppRemember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. /ph3About Innovative Medicine /h3pOur 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. /ppJoin us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. /ppLearn more at /ppWe are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Beerse, Belgium or Warsaw, Poland. /ph3Purpose: /h3pGlobal 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. /ppThe 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): /ppPrimary labeling documents (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI)) /ppDerived labeling documents /ppOur Vision and Mission articulate Global Labeling's commitment to providing high‑quality, compliant, and timely labeling that supports our stakeholders and patients worldwide. /ph3You will be responsible for: /h3ulliLeading 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. /liliMaking 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. /liliContributing 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. /liliContributing to the continuous improvement of the end-to-end labeling process. /li /ulh3Qualifications /

Requirements:
/h3ulliA minimum of Bachelor's degree in a scientific discipline is required. An advanced degree (MS, PhD, MD or PharmD) is preferred. /liliA minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required. /liliA minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is preferred. /liliAn understanding of pharmaceutical drug development is required. /liliExperience in discussing and communicating scientific concepts is required. /liliBasic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required. /liliExperience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision is required. /liliA demonstrated proactive approach, experience participating in continuous improvement projects, and excepti /li /ul