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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 Product Submissions and Registration

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

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-003029

• United Kingdom, Belgium, Netherlands - Requisition Number: R-006636

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 Global Labeling Operations Specialist. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.

The Global Labeling Operations Specialist will be responsible for the following:

• Act in role of Reference Safety Information (RSI) steward in support of Clinical Trial management, including monitoring changes to comparator labels. Communicate changes to Clinical, Safety, and Regulatory teams in accordance with documented timelines; and tracking completion of impact assessments.

• Track key labeling milestones and deliverables using tracking tools, document repositories, and other related systems and technologies.

• Support the development, preparation, monitoring, and communication of Key Performance Indicators (KPIs) and metrics related to comparator labels and other labeling outputs and processes.

• Manage/monitor process communications, department mailboxes, and collaboration portals.

• Provide input and support for audits and inspections.

• Support process improvements and successful communication and collaboration within Global Labeling and across business partners.

Qualifications:

• A minimum of a Bachelor’s degree is required, preferably in a scientific discipline.

• A minimum 3 years of experience supporting labeling development, implementation, and/or operations within the Pharmaceutical industry or experience supporting Regulatory processes associated with clinical trial management and execution is required.

• An understanding of the pharmaceutical development process is required.

• Knowledge of labeling processes and systems is required.

• Knowledge of clinical trial legislation, management, and associated labeling requirements preferred.

• Experience supporting clinical trials in a pharmaceutical setting is preferred.

• Experience monitoring deliverables and milestones within labeling or other regulatory processes preferred.

• Experience planning, scheduling, facilitating meetings across stakeholder groups is preferred.

• Experience working with dashboards and metrics (e.g., Tableau) is preferred.

• Experience with Microsoft Teams tools and apps is preferred

• Must have excellent verbal and written communication skills.

• Must have strong organizational and collaboration skills.

The anticipated base pay range for this position in all other U.S. locations is $89,000 to $143,750.

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 April 10, 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.

#LI-Hybrid

The anticipated base pay range for this position is :

The anticipated base pay range for this position in all other U.S. locations is $89,000 to $143,750.

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.