Assoc. Director Global Labeling Product Leader

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 in Raritan, NJ or other locations may be considered (Titusville, NJ, Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland Allschwil, Bern, Zug) or Remote work options may be considered, on a case-by-case basis and if approved by the Company.

Our company thrives on a 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.

Key Responsibilities:

- 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 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 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 and implement the global labeling strategy including the development of target labeling.
- Contribute to the continuous improvement of the end-to-end labeling process.

**Qualifications**
Education
- A minimum of Bachelor’s degree (or equivalent) is required.
- A degree in scientific discipline (highly preferred)
- An advanced degree (MS, PhD, MD or PharmD) (highly preferred)

**Required Skills**:

- Minimum of 8 years professional experience
- 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
- An understanding of prescription pharmaceutical drug development

Preferred Skills:

- Previous experience working within a regulatory labeling function developing labeling content for pharmaceutical products
- Experience working in documentum-based systems
- Experience leading project teams
- Solid understanding of biology and pharmacology
- A demonstrated proactive approach, experience leading continuous improvement projects, and exceptional verbal and written communication, negotiation and partnering skills
- Demonstrated ability to drive a collaborative, customer-focused, learning culture

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.

The base pay range for this position is $129,500 to $194,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below

**Primary Location**
United States-New Jersey-Raritan-920 US Highway 202
**Other Locations**
North America-Canada-Ontario-Toronto, North America-Canada, Europe/Middle East/Africa-Switzerland-Allschwil, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Berne-Bern, North America-United States, North America-United States-Pennsylvania