Global Labeling Manager

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Global Labeling Manager in Titusville, NJ, Raritan, NJ or Spring House, PA, Toronto, Ontario (CA), UK (High Wycombe), Netherlands (Leiden), Belgium (Beerse), or Switzerland (Allschwil, Bern, Zug).

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.

**Key Responsibilities**:

- Leads the implementation activities for labeling under the responsibility of the GL CoE. This includes:

- Provision of deliverables for USPI and associated labeling, including SPL, as appropriate.
- Requesting, reviewing, and approving US production artwork in the designated electronic artwork management system.
- Tracking implementation of artwork for safety changes and other types of labeling issued.

2. Provides timely and correct input and entries as needed in departmental labeling and project trackers.

3. Actively participates on labeling project teams for the development of new or updated mock-ups and artwork in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork COE and others as needed.

4. Actively participates on New Product Launch Teams or Supply Chain-led labeling or packaging initiatives on behalf of the GL CoE to provide technical expertise with respect to packaging component text content as well as the requirements for layout and design.

5. Manages US labeling mock-ups for use in submission to Health Authority.

6. Engages in the development of packaging text for US labeling.

7. Updates labeling history documents related to product artwork changes.

8. Obtains and prepares labeling implementation input for US Annual Reports.

9. Assigns National Drug Code (NDC) numbers and maintains NDC log for Janssen and Patriot Pharmaceutical US-marketed products.

10. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.

11. Supports the Legal Department with litigation efforts related to GL CoE-managed labeling, as needed.

12. Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.

13. Actively participates in or provides leadership of process improvement initiatives.

14. Support audits and inspections as needed.

**Qualifications** Education**:

- University Degree (i.e., Bachelor’s degree) required

**Experience and Skills**:
**Required**:

- 6 years relevant experience (including 2+ years health care industry)
- Strong verbal and written communication, negotiation, and partnering skills
- E2E labeling knowledge
- Process Improvement knowledge
- Track record of managing projects through to successful completion
- Experience successfully working with and/or leading cross-functional teams
- Experience working with external providers
- Experience with labeling submission planning and implementation

**Preferred**:

- Previous experience working within a regulatory labeling function developing packaging content and managing artwork implementation for pharmaceutical products
- Experience working in artwork management systems
- Experience leading project teams
- 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 is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

**Primary Location**
United States-New Jersey-Titusville-1125 Trenton Harbourton Road

**Other Locations**
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Switzerland-Allschwil, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, North America-United States-Pennsylvania-Spring House, North America-Canada-Ontario-Toronto, Europe/Middle East/Africa-Belgium-Antwerp-Beerse

**Organization**
Janssen Research & Development, LLC (6084)

**Job Function**
Regulatory Affairs

**Requisition ID**
2206050873W