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Associate Director, Global Labeling Product Leader

Company: Janssen
Location: Titusville
Posted on: June 23, 2022

Job Description:

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Global Labeling Product Leader in Titusville, NJ, Raritan, NJ or Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug) or Remote work options may be considered, on a case-by-case basis and if approved by the Company.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.Our company thrives on 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 and 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:Have oversight and responsibility for the development, revision, review, approval and maintenance of primary and derived labeling documents for assigned compounds in assigned portfolio.Manage compounds with a certain degree of complexity from a labeling perspective.Create and maintain primary labeling documents 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).Coordinate the development, revision, review, and approval of primary and derived labeling documents, including the Labeling Working Group (LWG) and Labeling Committee (LC) activities related to these documents.Ensure the dissemination of LC-approved CCDS, USPI, EUPI, and derived labeling documents and supporting documentation; ensure the quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).Contribute to and implement the global labeling strategy including the development of target labeling.Contribute to the continuous improvement of the end-to-end labeling process.QualificationsQualificationsEducation:A minimum of a Bachelors degree or equivalent is required.A degree in a scientific subject area (highly preferred)An advanced degree (MS, PhD, MD or PharmD) (is highly preferred)Experience and Skills:Required:Minimum of 8 years of professional experienceRelevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience or equivalentAn understanding of prescription pharmaceutical drug developmentPreferred:Previous experience working within a regulatory labeling function developing labeling content for pharmaceutical productsExperience working in Documentum-based systemsExperience leading project teamsSolid understanding of biology and pharmacologyA demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, negotiation, and partnering skillsDemonstrated ability to drive a collaborative, customer-focused, learning cultureOther:At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through groundbreaking programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to employment to support the well-being of our employees, their families, and the communities in which we live and work.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.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.Primary LocationUnited Kingdom-England-High Wycombe-Other LocationsEurope/Middle East/Africa-Netherlands, Europe/Middle East/Africa-Switzerland, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium, North America-United States-Pennsylvania-Spring House, Canada-Ontario-Toronto, United States-New Jersey-TitusvilleOrganizationJanssen Cilag Ltd. (7360)Job FunctionRegulatory AffairsRequisition ID2206042347W

Keywords: Janssen, Trenton , Associate Director, Global Labeling Product Leader, Executive , Titusville, New Jersey

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