Manager, Global Labeling Operations

Johnson & Johnson Innovative Medicine•Horsham, PA

8d•Hybrid

About The Position

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:

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.
Knowledge of labeling processes and systems is 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.

Nice To Haves

Experience in the Pharmaceutical industry is preferred.
An understanding of pharmaceutical drug development is preferred.
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.
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.

Responsibilities

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 Labeling 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.

Benefits

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 Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits