Johnson & Johnson Innovative Medicine
Senior Manager, Global Labeling Product Leader
Johnson & Johnson Innovative Medicine, Horsham, Pennsylvania, United States, 19044
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Senior Manager, Global Labeling Product Leader
role at
Johnson & Johnson Innovative Medicine .
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 to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Requisition Numbers
United States - Requisition Number: R-042465
Belgium, Poland - Requisition Number: R-043330
United Kingdom - Requisition Number: R-044318
Switzerland - Requisition Number: R-044319
Brazil - Requisition Number: R-044320
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.
Responsibilities
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 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. 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 application 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.
Required Skills
Analytical Reasoning
Business Writing
Fact-Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Preferred Skills
Analytical Reasoning
Business Writing
Fact-Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Base Pay Range The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750.
Benefits 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)).
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 - 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
EEO Statement 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.
Application Deadline This job posting is anticipated to close on November 28, 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.
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Senior Manager, Global Labeling Product Leader
role at
Johnson & Johnson Innovative Medicine .
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 to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Requisition Numbers
United States - Requisition Number: R-042465
Belgium, Poland - Requisition Number: R-043330
United Kingdom - Requisition Number: R-044318
Switzerland - Requisition Number: R-044319
Brazil - Requisition Number: R-044320
Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Raritan, NJ; Titusville, NJ; or Horsham, PA.
Responsibilities
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 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. 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 application 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.
Required Skills
Analytical Reasoning
Business Writing
Fact-Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Preferred Skills
Analytical Reasoning
Business Writing
Fact-Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
Base Pay Range The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750.
Benefits 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)).
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 - 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
EEO Statement 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.
Application Deadline This job posting is anticipated to close on November 28, 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.
#J-18808-Ljbffr