Johnson & Johnson is recruiting for a Manager, Global Labeling Operations to be located in Raritan, NJ, Titusville, NJ, or Horsham, PA.
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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
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Key Responsibilities:
Leads the implementation activities for labeling under the responsibility of Global Labeling Operations, including :
- Provision of Regulatory guidance on the development of US packaging text for labeling mockups and production artwork.
- Requesting, reviewing, and approving 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-US labeling in scope of GL.
- Tracking implementation of artwork for safety changes and other types of labeling issued.
- Completing or providing input into Change Controls related to labeling implementation or delisting activities.
- Actively participates 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.
- Provides timely and correct input and entries as needed in departmental labeling and project trackers. Updates labeling history documents related to product artwork changes.
- Obtains and prepares labeling implementation input for US Annual Reports.
- Assigns National Drug Code (NDC) numbers and maintains NDC log for J&J IM and Patriot Pharmaceutical US-marketed products. Supports Establishment Registrations, Drug Listing, and Structured Product Labeling (SPL) for US-marketed products.
- Supports the Legal Department with litigation efforts related to GL-managed labeling, as needed.
- Provides feedback on US Product Quality Complaints (PQC) related to product labeling and packaging artwork.
- Actively participates in or provides leadership of process improvement initiatives.
- Support audits and inspections as needed.
Qualifications
Education:
- A minimum of Bachelor's degree (or equivalent) is required
Experience and Skills:
Required:
- Minimum of 4 years of relevant experience supporting labeling development, implementation, or operations in the Pharmaceutical industry is required
- Knowledge of labeling processes and systems is required
- Understanding of audit and inspection processes and deliverables is required
- A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills is required
Preferred:
- Project or program management experience, experience in program/project management of quality and compliance activities associated with pharmaceutical labeling is preferred
- Planning, scheduling, facilitating meetings across broad stakeholder groups is preferred
- A successful track record of effectively/appropriately prioritizing and managing multiple projects simultaneously is preferred
- Experience working with dashboards and metrics (e.g., Tableau) and Microsoft Teams tools and apps is preferred
- Comfortable with developing/delivering communications in a variety of settings for diverse audiences (e.g., announcements, newsletters, presentations) is preferred
- An understanding of pharmaceutical drug development is preferred
- Demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred
The anticipated base pay range for this position is $115,000 - $197,800 USD
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.
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
Additional information can be found through the link below.
For additional general information on Company benefits, please go to:
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com