Senior Manager, Global Labeling Product Leader

Overview

This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. 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 Med Tech, 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

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania;
Raritan, New Jersey;
Titusville, New Jersey

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

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-042465
• Belgium, Poland - Requisition Number: R-043330
• United Kingdom - Requisition Number: R-044318
• Switzerland - Requisition Number: R-044319
• Brazil - Requisition Number: R-044320

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 Senior Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ;
Titusville, NJ; or Horsham, PA.

• Lead the development, revision, review, agreement, and maintenance of primary labeling (CCDS, USPI, patient labeling, EU Product Information, and derived labeling) for assigned compounds.
• Provide recommendations and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate resolution of labeling issues with potential impact on labeling and documentation. Ensure high quality and compliant labeling documents. This role may collaborate with external partners.
• Contribute to and implement the global labeling strategy, including competitive awareness and knowledge of labeling for development of labeling and target labeling.
• Contribute to continuous improvement of the end-to-end labeling process.

• Bachelor's degree in a scientific discipline required; advanced degree (MS/PhD/Pharm
  
  D) preferred.
• Minimum 8 years of professional experience; minimum 6 years direct regulatory labeling content experience in pharmaceutical products or equivalent.
• Relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
• Understanding of pharmaceutical drug development and worldwide regulatory guidelines for labeling.
• Experience leading project teams in a matrix environment and leading continuous improvement projects.
• Experience with document management systems; ability to prioritize and manage multiple products and projects.
• Exceptional verbal and written communication skills; strong organizational, negotiation, and partnering skills; ability to work independently.
• Preferred: ability to manage compounds with labeling complexity and drive a collaborative, customer-focused, learning culture.

The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750. The Company maintains highly competitive, performance-based compensation programs. Eligible for an annual performance bonus. Benefits include medical, dental,…