Manager, Global Labeling Product Leader
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Horsham • New Jersey • Pennsylvania • United States
Visit company websiteExplore more
Salary
💰 $117,000 - $201,250 per year
Job Level
About the role
- 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.
- Contribute 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.
- Contribute to the continuous improvement of the end-to-end labeling process.
Requirements
- 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 4 years of relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.) is required.
- A minimum of 3 years of Regulatory Affairs 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 in a matrix environment is required.
- Experience participating in 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 drive a collaborative, customer-focused, learning culture is preferred.
Benefits
- Annual performance bonus
- Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
- Eligible to participate in the Company’s long-term incentive program
- 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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
labeling regulationsRegulatory Affairspharmaceutical drug developmentdocument management systemslabeling contentscientific integritycontinuous improvementproject managementmatrix environmentpharmacovigilance
Soft Skills
verbal communicationwritten communicationorganizational skillsnegotiation skillspartnering skillsindependencecollaborationcustomer focuslearning culturescientific communication
Certifications
Bachelor’s degreeMaster’s degreePhDPharmD