Johnson & Johnson Innovative Medicine is recruiting for an Associate Director, RA Labeling Product Leader (1 of 2) in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland). At 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 https://www.nj.om/ . Our company thrives on a diverse company culture, celebrating the uniqueness of our employees, and is committed to inclusion. Janssen is proud to be an equal-opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, helps its employees achieve an effective balance between work and home life, and supports their efforts to have a positive impact on their communities.
Key Responsibilities Lead 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)).
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.
Qualifications Education: A bachelor's degree (or equivalent) in a scientific discipline is required. An advanced degree (MS, PhD, MD, or PharmD) in a scientific discipline is preferred.
Experience and Skills:
Minimum of 8 years of professional experience.
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent experience.
An understanding of pharmaceutical drug development.
Experience in discussing and communicating scientific concepts.
Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.
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