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.
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
Our Vision and Mission articulate Global Labeling's commitment to providing high-quality, compliant, and timely labeling that supports our stakeholders and patients worldwide.
You will be responsible for:- 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.
#LI-HybridRequired 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
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
