Associate Director, Global Labeling Product Leader - Johnson & Johnson Innovative Medicine, High Wycombe, United Kingdom (Hybrid)
Johnson & Johnson Innovative Medicine is a global leader in medical innovation, committed to preventing, treating, and curing complex diseases and improving health worldwide.
Job Function
* Regulatory Affairs / Product Management and Marketing
Key Responsibilities
* Drive the global labeling strategy, including competitor analysis and labeling development for new products.
* Partner with Global Regulatory Leads and cross-functional teams (clinical, safety, market access, commercial, medical affairs) to align labeling strategy with regulatory and product strategy.
* Lead target labeling development and provide strategic labeling advice for local markets.
* Collaborate on clinical study protocol labeling input, ensuring alignment on endpoints and patient-reported outcomes.
* Analyze competitor labeling and industry guidance to develop strategy, risk mitigation, and contingency plans.
* Lead development, revision, agreement, and maintenance of target and primary labeling documents (CCDS, USPI, EUPI).
* Manage the Labeling Working Group (LWG) and represent global labeling in regulatory and cross-functional meetings.
* Present at governance meetings, coordinate labeling issue resolution, and ensure high-quality compliant documents.
* Contribute to continuous improvement of the end-to-end labeling process.
* Support global labeling inspections and audits as required.
Qualifications
* Bachelor’s degree in a scientific discipline (Master’s/PhD preferred).
* Minimum 8 years of professional experience, 6 years of direct regulatory labeling content experience.
* Experience with target labeling development or NME submissions preferred.
* Relevant pharma industry experience (Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance).
* Understanding of pharmaceutical drug development and worldwide regulatory guidelines.
* Strong communication, organizational, negotiation, and partnering skills; ability to work independently.
* Experience leading project teams in a matrix environment and continuous improvement projects.
* Experience managing multiple products and projects simultaneously.
* Proficiency with document management systems.
This role is eligible for referrals and is open to capable candidates at Johnson & Johnson Innovative Medicine.
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