Manager, Global Labeling Operations

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

• United States - Requisition Number: R-028412

• United Kingdom - Requisition Number R-029453

• Netherlands, Belgium, Poland - Requisition Number: R-029457

• Switzerland - Requisition Number: R-029459

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Global Labeling Operations. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

The Manager, Global Labeling Operations will be responsible for the following:

• Lead the implementation activities for labeling under the responsibility of Global Labeling (GL) Operations, including:

  • Provision of Regulatory guidance on the development of U.S. packaging text for labeling mockups and production artwork.

  • Request, review, and approve mockups and production artwork in the designated electronic artwork management system.

  • Management of labeling implementation inputs and deliverables for registration sample packs, Software as a Medical Device (SaMD), and other non-U.S. labeling in scope of GL.

  • Track implementation of artwork for safety changes and other types of labeling issued.

  • Complete or provide input into Change Controls related to labeling implementation or delisting activities.

• Actively participate on project teams for launches, lifecycle changes, and Supply Chain-led labeling or packaging initiatives in partnership with Global Labelling Product Leaders, Supply Chain, Marketing, Regulatory Affairs, CMC Regulatory Affairs, Product Artwork, and others as needed.

• Provide timely and correct input and entries as needed in departmental labeling and project trackers. Update labeling history documents related to product artwork changes.

• Obtain and prepare labeling implementation input for U.S. Annual Reports.

• Assign National Drug Code (NDC) numbers and maintains NDC log for Johnson & Johnson Innovate Medicine and Patriot Pharmaceutical U.S.-marketed products. Support Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for U.S.-marketed products.

• Support the Legal Department with litigation efforts related to GL-managed labeling, as needed.

• Provide feedback on U.S. Product Quality Complaints (PQC) related to product labeling and packaging artwork.

• Actively participate in or provide leadership of process improvement initiatives.

• Support audits and inspections, as needed.

Qualifications:

• A minimum of a Bachelor’s degree is required, preferably in a scientific discipline.

• A minimum of 4 years of relevant experience supporting labeling development, implementation, or operations is required.

• Experience in the Pharmaceutical industry is preferred.

• An understanding of pharmaceutical drug development is preferred.

• Knowledge of labeling processes and systems is required

• Understanding of audit and inspection processes and deliverables is preferred.

• Experience participating in continuous improvement projects is preferred.

• Experience in program/project management of quality and compliance activities associated with pharmaceutical labeling is preferred.

• Experience effectively/appropriately prioritizing and managing multiple projects simultaneously is preferred.

• Experience planning, scheduling, facilitating meetings across stakeholder groups is preferred.

• Experience working with dashboards and metrics (e.g., Tableau) preferred.

• Experience with Microsoft Office (Work, Excel, PowerPoint, Outlook), Teams tools and apps required.

• Must have excellent verbal and written communication skills.

• Must have strong organizational and negotiation skills.

• The ability to partner with cross-functional teams is required.

• The ability to drive a collaborative, customer-focused, learning culture is preferred.

• The ability to develop/deliver communications in a variety of settings for diverse audiences (e.g., announcements, newsletters, presentations) is preferred.

The anticipated base pay range for U.S. locations is $100,000 to $172,500.

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 and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to:

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on September 3. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson are committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

The anticipated base pay range for this position is :

The anticipated base pay range for U.S. locations is $100,000 to $172,500.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below.