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 – Oncology/ Cardiovascular/ Metabolism TA. The position will be based at any of the following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring House, PA), 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.
The Associate Director 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 the Oncology/Cardiovascular/Metabolism portfolio.
• Manage compounds with a certain degree of complexity from a labeling perspective.
• Creation and maintenance of 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
• Coordination of 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
• Ensuring the dissemination of LC-approved CCDS, USPI, EUPI and derived labeling documents and supporting documentation; ensuring quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents)
• Contributing to the continuous improvement of the end-to-end labeling process
• Contributing to and implementing the global labeling strategy including the development of target labeling.
• A minimum of Bachelor’s degree (or equivalent) in a scientific discipline is required
• An advanced degree (MS, PhD, MD or PharmD) is highly desired
• Minimum of 8 years professional experience required
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling experience is required
• Experience developing labeling content for pharmaceutical products required
• Experience working in documentum-based systems preferred
• Experience leading project teams is preferred
• An understanding of prescription pharmaceutical drug development is required
• Solid understanding of biology and pharmacology is highly desired
• A demonstrated proactive approach and focus on continuous improvement, and exceptional verbal and written communication, negotiation and partnering skills are highly desired
• Demonstrated ability to drive a collaborative, customer-focused, learning culture is highly 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), 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-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Janssen Research & Development, LLC. (6084)
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