Senior Manager, Global Labeling Implementation

Johnson & Johnson Innovative Medicine is recruiting for a Senior Manager, Global Labeling Implementation in Raritan, NJ; Titusville, NJ; Horsham, PA; UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Toronto (Canada); or Allschwil, Bern, Zug (Switzerland).,

• Is responsible for labeling implementation processes and activities in support of US product launches and labeling lifecycle updates, including artwork management, Change Control input, and timely completion of labeling history documents and labeling input for Annual Reports.
• National Drug Code (NDC) and Global Trade Identification Number (GTIN) assignment and enumeration for new products and/or package configurations.
• Provides guidance and support for the US drug listings and Structured Product Labeling (SPL). Partners with an external service provider to deliver on regulatory commitments.
• Timely evaluation and response to Product Quality Complaints (PQCs) related to labeling artwork.
• Conducts periodic labeling gap assessments to ensure processes and metrics meet current business needs.
• Ensures that the team has the necessary resources and knowledge to develop and implement strategies for optimizing processes, systems, and tools to anticipate/meet business changing needs.
• Develops, monitors, and manages budget, workload, and resource management.
• Coaches and trains staff in labeling regulations and guidance, with a focus on developing excellence in labeling processes, standards and compliance.
• Builds talent by giving constructive feedback on performance; including, clear direction related to goals and objectives. Holds direct reports accountable to deliver results and provides/supports development opportunities and stretch assignments.
• Performs people management tasks such as Performance Management, Compensation, and Career Planning.
• Supports compliance activities including audits, inspections, and labeling-related escalations and non-conformances., 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 of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
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. Related Jobs You might be interested Senior Director, Global Leader Unified Regulatory Platform (URP) Program, RODI
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  University Degree (minimum of Bachelor's degree or equivalent)., 8 years relevant experience (including 4+ years health care industry of which 2 are in product labeling/labeling regulations).
• People management experience (2+ years preferred).
• End-to-end labeling knowledge.
• Knowledge of US labeling regulations and packaging content requirements for Pharmaceutical and Biologic products.
• Strong verbal and written communication, negotiation, and collaboration skills.
• Process Improvement knowledge and experience as a change leader.
• Track record of leading projects through to successful completion.
• Experience successfully working with and/or leading cross-functional teams.
• Experience working with external service providers and vendors.
Preferred:
• Experience assigning NDCs
• Understanding of barcoding elements and use on pharmaceutical packaging
• Knowledge/understanding of trends and technologies supporting Digital Labeling
• Experience with Artwork Management systems and Electronic Proofreading technology
• Project or program management experience, experience in program/project management of quality and compliance activities associated with pharmaceutical labeling is a plus
• Planning, scheduling, facilitating meetings across broad groups
• Proven ability to effectively/appropriately prioritize and manage multiple projects simultaneously
• Experience working with dashboards and metrics (e.g., Tableau) and Microsoft Teams tools and apps
• Comfortable with developing/delivering communications in a variety of settings for diverse audiences (e.g., announcements, newsletters, presentations)
• An understanding of pharmaceutical drug development
• Past success in driving a collaborative, customer-focused, learning culture
  
  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. 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. At Johnson & Johnson, we all belong.