Lead the implementation activities for labeling under the responsibility of Global Labeling (GL) Operations.
Provide 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.
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 maintain NDC log for Johnson & Johnson Innovate Medicine 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 for process improvement initiatives.
Support audits and inspections as needed.

Requirements

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.
Experience with NDA or BLA launches preferred.
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 (Word, Excel, PowerPoint, Outlook), Teams tools and apps required.

Benefits

Health insurance
401(k) matching
Paid time off
Remote work options
Performance-based bonuses
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
Holiday pay – 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
Bereavement Leave – 240 hours for immediate family members; 40 hours for extended family members per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

labeling developmentlabeling implementationregulatory guidanceChange Controlspharmaceutical drug developmentNDA launchesBLA launchesquality and compliance activitiesproject managementcontinuous improvement

Soft Skills

leadershipprioritizationproject managementstakeholder managementcommunication