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Associate Director, Global Labeling Product Leader

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Job Details
Job Order Number
Company Name
J&J Family of Companies
Physical Address

Dover, DE 19904
Job Description

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 for more

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 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

+ 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

+ 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


+ 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

+ 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.

Primary Location

United States-New Jersey-Raritan-

Other Locations

Europe/Middle East/Africa-Netherlands, North America-Canada, North America-United States, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-United Kingdom, 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)

Job Function

Regulatory Affairs

Requisition ID


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