Global Labeling Postgraduate Associate

Johnson & Johnson • Titusville, NJ

20h • $92,000 - $148,350 • Hybrid

About The Position

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. 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. 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.

Requirements

• A minimum of a Master’s degree in a scientific discipline from a 4-year university program is required.
• Candidates must also have earned or be currently pursuing an advanced degree (PhD/PharmD/MD level) in a scientific discipline from an accredited academic institution.
• Examples include biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy or other healthcare science.
• Strong academic track record required.
• Must have excellent communication skills.
• Must be able to work independently, as well as part of a group, with curiosity and flexibility.
• Must be self-motivated, possess a proactive approach, and be confident to speak your voice and suggest innovative ideas.
• Must be a creative problem solver, with an interest in exploring the international context of healthcare systems and technology contexts.

Nice To Haves

• Some fundamental understanding of pharmaceutical drug development is preferred.
• Regulatory Affairs experience is preferred.
• Knowledge of current Food and Drug Administration (FDA) regulations, European Medicines Agency (EMA) guidelines, and submission requirements preferred.
• Proven leadership capabilities in an organizational setting (campus/community activities) preferred.

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.
• 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, including demonstrating an understanding of competitors in the therapeutic area and in labeling regulations.
• Ensuring high quality and compliant labeling documents.
• Contributing to the continuous improvement of the end-to-end labeling process or department workstreams/initiatives.

Benefits

• 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.
• Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
• Vacation - 120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington - 56 hours per calendar year
• Holiday pay, including Floating Holidays - 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave - 10 days
• Volunteer Leave - 4 days
• Military Spouse Time-Off - 80 hours
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

What This Job Offers

• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees