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Manager, Global Labeling Product Leader
Johnson & JohnsonCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in pharmaceutical labeling processes and regulatory affairs, with a strong focus on developing and maintaining compliant labeling documents. Proven ability to lead project teams and contribute to continuous improvement initiatives within the pharmaceutical industry.
Highest-signal resume keywords
Regulatory Affairs ExperiencePharmaceutical Drug DevelopmentLabeling Regulations KnowledgeDocument Management Systems ExperienceProject Team Leadership
About the role
Key responsibilities & impact- Lead the development, revision, review, agreement, and maintenance of primary labeling, including CCDS, USPI and associated patient labeling, and EUPI, for assigned compounds
- Lead development and maintenance of derived labeling documents for EU and US
- Make recommendations and provide advice and guidance on labeling content, processes, timelines, and scientific integrity
- Coordinate resolution of labeling issues affecting primary or derived labeling and supporting documentation
- Ensure high-quality and compliant labeling documents
- Contribute to global labeling strategy, including analysis of therapeutic-area competitors and their development plans and status
- Apply knowledge of labeling aspects to development of labeling and target labeling
- Contribute to continuous improvement of the end-to-end labeling process
Requirements
What you’ll need- Minimum of Bachelor’s degree in a scientific discipline required
- Minimum of 4 years of relevant experience in the pharmaceutical industry required
- Minimum of 3 years of Regulatory Affairs experience with product labeling/labeling regulations, or equivalent preferred
- Understanding of pharmaceutical drug development required
- Experience discussing and communicating scientific concepts required
- Basic understanding of worldwide regulatory guidelines and their applications to labeling required
- Experience leading project teams within a matrix environment required
- Ability to work largely independently with limited supervision required
- Proactive approach and experience participating in continuous improvement projects required
- Exceptional verbal and written communication, organizational, negotiation, and partnering skills required
- Experience working in document management systems required
- Successful track record prioritizing and managing multiple products and projects simultaneously preferred
- Demonstrated ability to drive a collaborative, customer-focused, learning culture preferred
- Advanced degree (MS, PhD, MD, or PharmD) preferred
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year; 48 hours for employees residing in Colorado; 56 hours for employees residing in Washington
- 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 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
- Employee benefits information available through the company benefits program
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Labeling Document DevelopmentLabeling Content AnalysisTherapeutic-Area Competitor AnalysisContinuous Improvement MethodologiesScientific Concept Communication
Soft Skills
Exceptional Verbal CommunicationOrganizational SkillsNegotiation SkillsPartnering SkillsProactive Approach
Certifications & Qualifications
Bachelor’s Degree in Scientific DisciplineAdvanced Degree (MS, PhD, MD, or PharmD)
Industry Keywords
Pharmaceutical IndustryLabeling ComplianceWorldwide Regulatory GuidelinesMatrix EnvironmentCustomer-Focused Culture