Senior Manager, Global Labeling Product Leader
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Raritan • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $137,000 - $235,750 per year
Job Level
Senior
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.
- 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.
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 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.
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- 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 - 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory labeling contentlabeling document developmentscientific integritypharmaceutical drug developmentcontinuous improvement projectsproject managementdocument management systemslabeling strategy implementationlabeling compliancelabeling text development
Soft skills
verbal communicationwritten communicationorganizational skillsnegotiation skillspartnering skillsindependent workcollaborationcustomer focusproblem-solvingprioritization
Certifications
Bachelor’s degreeMaster’s degreePhDPharmD