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 https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Product Submissions and Registration

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Leiden, Netherlands, Warsaw, Masovian, Poland

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 https://www.jnj.com/innovative-medicine

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 Leiden, Netherlands; Beerse, Belgium; or Warsaw, Poland.

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.

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