Associate Director, RA Labeling Product Leader (1 of 2)

Job Description - Associate Director, RA Labeling Product Leader (1 of 2) (2406187352W)Position OverviewJohnson & 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.Key Responsibilities:Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI), 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.Contribute to and implement the global labeling strategy, demonstrating understanding of competitors in the therapeutic area and their development plans and status.Contribute to the continuous improvement of the end-to-end labeling process.QualificationsEducation: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:Required: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.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.Experience leading project teams within a matrix environment, combined with the ability to work independently.A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation, and partnering skills.Preferred:Ability to manage compounds with a certain degree of complexity from a labeling perspective.A successful track record of effectively prioritizing and managing multiple products and projects simultaneously.Demonstrated ability to drive a collaborative, customer-focused, learning culture.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #J-18808-Ljbffr