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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

US054 PA Horsham - 200 Tournament Dr, US063 NJ Raritan - 920 US Hwy 202, US159 NJ Titusville - 1125 Trenton-Harbourton Rd

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

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-000701

• Canada - Requisition Number: R-002921

• Belgium, United Kingdom, Switzerland - Requisition Number: R-002952

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are currently seeking an Associate Director, Global Labeling Product Leader. This position can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

The Associate Director, Global Labeling Product Leader will be responsible for the following:

• Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds.

• Make recommendations and provides advice and guidance about labeling content, processes, timelines, and scientific integrity. Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation. Ensure high quality and compliant labeling documents. This role may collaborate with external partners.

• Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status and knowledge of labeling aspects for the development of labeling and target labeling.

• Contribute to the continuous improvement of the end-to-end labeling process.

Qualifications:

• A minimum of a Bachelor’s degree in a scientific discipline is required. Advanced degree (Master’s PhD, PharmD) in a scientific discipline is preferred.

• A minimum of 8 years of professional work experience is required.

• A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.

• Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.

• An understanding of pharmaceutical drug development is required.

• Experience in discussing and communicating scientific concepts is required.

• Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.

• Experience leading project teams in a matrix environment is required.

• Experience leading continuous improvement projects is required.

• Experience working with document management systems is required.

• Experience effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.

• Must have exceptional verbal and written communication skills.

• Must have strong organizational, negotiation, and partnering skills.

• Must have the ability to work independently.

• The ability to manage compounds with a certain degree of complexity from a labeling perspective is preferred.

• The ability to drive a collaborative, customer-focused, learning culture is preferred.

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. 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

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: 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.

This job posting is anticipated to close on March 24, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750.

Additional Description for Pay Transparency:

For US: Calculate the salary to be included based on the compensation range provided in the requisition. Duplicate the WR window to access the details. As applicable for your role: Step 1: Review Pay Transparency Compliance Work Instructions for Talent Acquisition - United States Step 2: Manually include the minimum salary to 115% of the midpoint. Please follow the guidelines for exceptions (LDP, Coops, 100% commissions, Fixed salary, Sales and releveling) Step 3: Please copy the relevant benefits text based on the type of position and paste in the field: Additional Description for Pay Transparency. Step 4: If your primary, alternate, or remote location is in the California Bay Area, please manually add the applicable second range in the “Applicable Pay Range” field. DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION OR INCLUDE ANY ADDITIONAL BENEFITS APPLICABLE: 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)). This position is eligible to participate in the Company’s long-term incentive program. 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. http://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.