Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Global Labeling Product Leader. The position will be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), Canada (Toronto), UK (High Wycombe), Netherlands (Leiden), or Belgium (Beerse).
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information.
Under limited supervision, the Manager Global Labeling Product Leader will:
• Have oversight and responsibility for the development, revision, review, approval and maintenance of primary and derived labeling documents for assigned compounds in assigned portfolio.
• Create and maintain primary (Core Company Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)) and derived (International Package Insert, labeling text for EU, US and international package components, and translations) labeling documents
• 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 quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents)
• Contribute to the continuous improvement of the end-to-end labeling process
• Contribute to and implement the global labeling strategy including the development of target labeling.
• A University Degree (i.e., Bachelor’s degree (or equivalent)) in life sciences is required.
• An advanced degree (MS, PhD, MD, or PharmD) is desired.
• Minimum of 8 years of professional experience is required.
• Minimum of 4 years of pharmaceutical industry or health authority experience required.
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 3 years with experience in product labeling/labeling regulations, or equivalent is required.
• Technical, scientific, or regulatory writing experience is required.
• Basic understanding of the regulatory guidelines and their applications is required.
• A minimum of 1 year of experience leading teams within a matrix environment with an emphasis on collaborative, customer focused, and learning culture is required.
• An understanding of drug development is desired.
• Solid understanding of biology and pharmacology is highly desired.
• A demonstrated proactive approach and focus on continuous improvement, and strong verbal and written communication, and partnering skills are required.
• Strong Microsoft Word skills and experience working in a document management system. Basic Excel and PowerPoint skills required.
• Demonstrated collaborative, customer-focused, and learning mindset desired.
• Fluency (both oral and written) in English required.
• This position will be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), Canada (Toronto), UK (High Wycombe), Netherlands (Leiden), or Belgium (Beerse); and may require up to 10% domestic and international travel.
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J2W: LI NA
J2W: LI EMEA
United States-Pennsylvania-Spring House
North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
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