Manager, Global Labeling Product Leader

6084-Janssen Research & Development, LLC Legal Entity; Raritan (NJ); On-site; USD 117,000 - 201,000; Full time

Benefits offered by this job

401(k) plan

Vacation days

Sick leave

Parental leave

Job summary

Johnson & Johnson in New Jersey is seeking a Manager, Global Labeling Product Leader to shape labeling strategy across products and regions. You will lead cross-functional teams to ensure compliant labeling and lifecycle management from CCDS to USPI.

The role requires a scientific degree, 4+ years in pharma regulatory affairs, and strong writing and project-management skills. The position offers a hybrid work arrangement and comprehensive benefits.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Advanced degree (MS, PhD, MD or PharmD) is preferred.
• A minimum of 4 years of relevant experience in the pharmaceutical industry (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
• A minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations is preferred.
• Strong communication of scientific concepts is required.
• Experience leading project teams in a matrix environment is required.

Responsibilities

• Leading the development, revision, review, agreement, and maintenance of primary labeling (CCDS, USPI) and derived labeling documents.
• Providing guidance on labeling content, processes, timelines, and scientific integrity.
• Coordinate resolution of labeling issues with impact on primary or derived labeling.
• Ensure high quality, compliant labeling documents.
• Contribute to the global labeling strategy and continuous improvement of end-to-end labeling processes.

Skills

Analytical reasoning

Business writing

Coaching

Regulatory affairs management

Regulatory compliance

Regulatory development

Regulatory environment

Risk assessments

Strategic thinking

Technical credibility

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PhD, MD or PharmD) preferred

Tools

Document management systems

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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:

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-103361 Belgium and Poland- Requisition Number: R-106224 Switzerland - Requisition Number: R-106231 United Kingdom- Requisition Number: R-106250 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

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

We are searching for the best talent for our Manager, Global Labeling Product Leader to be based in Raritan, NJ; Titusville, NJ; or Horsham, PA.

Purpose: 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

Responsibilities:

• Leading the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, EU Product Information (EUPI)), and derived documents (labeling text for EU, US) for assigned compounds.
• Making recommendations and provide 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.
• Contributing to and participate in 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.
• Contributing to the continuous improvement of the end-to-end labeling process.

Qualifications / Requirements:

• A minimum of Bachelor’s degree in a scientific discipline is required.
• An advanced degree (MS, PhD, MD or PharmD) is preferred.
• A minimum of 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance) is required.
• A minimum of 3 years of Regulatory Affairs with experience in product labeling/labeling regulations, or equivalent is preferred.
• An understanding of pharmaceutical drug development is required.
• Experience in discussing and communicating scientific concepts is required.
• Basic understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required.
• Experience leading project teams within a matrix environment, combined with the ability to work largely independently with limited supervision is required.
• A demonstrated proactive approach, experience participating in continuous improvement projects, and exceptional verbal and written communication, organizational, negotiation and partnering skills is required.
• Experience working in document management systems is required.
• A successful track record of effectively/appropriately prioritizing and managing multiple products and projects simultaneously is preferred.
• Demonstrated ability to drive a collaborative, customer-focused, learning culture is preferred.

Required Skills: Preferred Skills:

• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact-Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Strategic Thinking
• Technical Credibility

Pay & Benefits:

The anticipated base pay range for this position is : $117,000.00 - $201,250.00

Additional Description for Pay Transparency:

• 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)).
• 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 Colorado –48 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 Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

#LI-Hybrid

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

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