Research & Development, L.L.C., a member of Johnson & Johnson's Family
of Companies, is recruiting for an Associate Director Global Labeling
Product Leader. The position can either be remote or based at any of the
following Janssen R&D sites: US (Titusville, NJ, Raritan, NJ or Spring
House, PA), Canada (Toronto, Ontario), 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.
In this role, you 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 or equivalent 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 can either be based
remotely or at any of the following Janssen R&D sites: US (Titusville, NJ,
Raritan, NJ or Spring House, PA), Canada (Toronto, Ontario), UK (High Wycombe),
Netherlands (Leiden), or Belgium (Beerse); and may require up to 10% domestic
and international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-New Jersey-Raritan-
North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Janssen Research & Development, LLC (6084)