Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Global Labeling Product. This position will be based at the following Janssen R&D sites: Titusville NJ, Raritan NJ or Spring House PA and may require up to 10% domestic and international travel.
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 assigned portfolio. • Manage compounds with a certain degree of complexity from a labeling perspective. • 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 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 content 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 the following Janssen R&D sites: Titusville NJ, Raritan NJ or Spring House PA and may require up to 10% domestic and international travel.
About Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies
Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We embrace innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make... every day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives.