Regulatory Affairs Labeling Product Manager

1 month ago

Birch Run, Michigan, United States Johnson & Johnson Full time

Overview:
At Johnson & Johnson Innovative Medicine, we are seeking a highly skilled professional for the role of Associate Director, RA Labeling Product Leader. This position is pivotal in shaping our regulatory labeling strategies and ensuring compliance across various markets.

Company Vision:
At Johnson & Johnson, we are committed to advancing health and well-being globally. Our innovative approach in healthcare allows us to tackle complex health challenges and deliver personalized solutions that enhance patient outcomes.

Core Responsibilities:
As the Associate Director, you will:

  • Oversee the creation, modification, and maintenance of essential labeling documents, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and EU Product Information (EUPI).
  • Provide expert recommendations and guidance on labeling content, timelines, and scientific accuracy.
  • Facilitate the resolution of labeling issues that may affect primary or derived labeling documents.
  • Ensure the production of high-quality, compliant labeling documentation, collaborating with external partners as necessary.
  • Contribute to the formulation and execution of the global labeling strategy, staying informed about competitive developments in the therapeutic landscape.
  • Drive continuous enhancements in the end-to-end labeling process.

Qualifications:
Education:
A bachelor's degree in a scientific field is required; an advanced degree (MS, PhD, MD, or PharmD) is preferred.

Experience and Skills:
Required:
Minimum of 8 years of relevant professional experience in the pharmaceutical sector, with at least 6 years focused on regulatory labeling content development. A solid understanding of pharmaceutical drug development processes is essential, along with experience in articulating scientific concepts clearly. Familiarity with global regulatory guidelines and their application to labeling is crucial. Proven leadership in project management within a matrix organization and the ability to work autonomously are necessary. Excellent communication, organizational, negotiation, and collaboration skills are required.

Preferred:
Experience managing complex labeling projects and a successful track record of prioritizing multiple initiatives effectively. A demonstrated ability to foster a collaborative and customer-centric culture is advantageous.

Compensation and Benefits:
The anticipated base pay range for this position is competitive, reflecting the skills and experience of the candidate. Johnson & Johnson offers a comprehensive benefits package, including medical, dental, vision, life insurance, and retirement plans. Employees may also enjoy generous time-off benefits.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace.

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