Manager Global Labeling Product Leader

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 can be 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), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug)).

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, 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.

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.

In this role, you will:

• Have responsibility for the development and maintenance of primary and derived labeling documents for assigned compounds in the assigned portfolio.
• Participate in the creation of, 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 internally approved CCDS, USPI, EUPI, and derived labeling documents and supporting documentation; work with other functions to ensure the quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
• Contribute to and participate in the global labeling strategy including the development of target labeling.
• Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications

• A minimum of Bachelor’s degree (or equivalent) is required.
• A degree in scientific discipline is highly preferred.
• An advanced degree (MS, PhD, MD or PharmD) is highly desired.
• Minimum of 4 years of professional experience required.
• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) including at least 3 years of direct regulatory labeling content experience or equivalent is highly desired.
• Previous experience working within a regulatory labeling function developing labeling content for pharmaceutical products is highly preferred.
• Experience working in documentum-based systems preferred
• Experience leading project teams is preferred
• An understanding of prescription pharmaceutical drug development is preferred
• Solid understanding of biology and pharmacology is highly desired
• A demonstrated proactive approach, and exceptional verbal and written communication, negotiation and partnering skills are highly desired.
• Participation in continuous improvement projects, and demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred.
• 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), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug); it 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.

Primary Location
United Kingdom-England-High Wycombe-
Other Locations
North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-Switzerland-Zug-Zug, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-New Jersey-Raritan, 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-Switzerland-Allschwil
Organization
Janssen Cilag Ltd. (7360)
Job Function
Regulatory Affairs
Requisition ID
2105962553W