Global Labeling Postgraduate Associate

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

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 https://www.jnj.com/innovative-medicine

Johnson & Johnson Innovative Medicine R&D is recruiting for a Global Labeling Postgraduate Associate within the Postgraduate Development Program.  This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

Fixed-Term role - Ineligibility for severance

Global Labeling (GL) is a function within Global Regulatory Affairs accountable for the strategic development and lifecycle management of product labeling across therapeutic areas, established products, regions, and affiliates.

The scope of Global Labeling covers the end-​to-end labeling process throughout the product’s lifecycle, from target labeling through the Company Core Data Sheet (CCDS):

• Primary labeling documents (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI)) .

• ​Derived labeling documents.

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Our Vision and Mission articulate Global Labeling’s commitment to providing high‑quality, compliant, and timely labeling that supports our stakeholders and patients worldwide.

Program Overview:

The Global Labeling (GL) Associate Program at Johnson & Johnson is a two-year experiential fellowship that provides recent university graduates with advanced, hands-on professional development at one of the world’s leading health care companies.  Under the mentorship of Johnson & Johnson GL professionals, GL associates may complete multiple rotations across different disease-therapeutic areas or specialize within a therapeutic area.

Principal Responsibilities:

• Develop a broad understanding of the global drug development lifecycle and related strategies for engaging health authorities.

• Learn the laws, guidances, and regulatory requirements for drugs and combination products while staying aligned with the organization’s goals.

• Tackle real-world projects that build your leadership presence, strengthen your ability to influence stakeholders, and enhance your collaboration, problem-solving, and presentation skills.

• Grow your professional network and cross-functional exposure while working with different teams.

• Under supervision by an experienced Global Labeling Product Leader (GLPL), the Associate will build the foundation for the following:

  • Contribute to the strategic development and lifecycle management of global labeling for assigned compounds, including drafting and shaping key sections of primary labeling (CCDS, USPI, EUPI and associated patient labeling), conducting competitive labeling analyses, and participating in cross functional discussions to support alignment and decision making.

  • Collaborating with cross-functional Labeling Working Group (LWG) on discussions leading to development of target and primary labeling.

  • Contributing to the global labeling strategy, i