About the Role Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director, Global Labeling Product Leader. This hybrid role can be located in Beerse, Belgium; Leiden, Netherlands; or Warsaw, Poland. The position is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. You can apply for any or all postings; all applications will be considered as a single submission.
Requisition Numbers United States – R-064124
United Kingdom – R-064828
Belgium, Netherlands, Poland – R-064832
Switzerland – R-064837
Responsibilities Drive the global labeling strategy, including understanding competitors, their development plans and status, and labeling aspects for development.
Take a leadership role and partner with Global Regulatory Leads (GRLs) and functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure alignment with the Global Regulatory and Product Strategy.
Lead target labeling development.
Collaborate with functional areas to provide labeling input relevant to clinical study protocols and ensure alignment on endpoints and Patient-Reported Outcomes (PROs) using a label-as-driver approach.
Provide strategic labeling advice for local labeling in major markets.
Analyze competitor labeling, leverage guidance and trends to develop strategy and content, including risk identification and mitigation.
Lead Health Authority (HA) labeling strategy discussions and develop contingency labeling plans and content.
Lead the development, revision, review, agreement, and maintenance of target labeling, primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI), patient labeling, European Union Product Information (EUPI), etc.) for assigned compounds.
Lead cross‑functional Labeling Working Group (LWG) and strategic labeling discussions for target and primary labeling.
Represent global labeling in Global Regulatory teams and other cross‑functional teams.
Present at governance meetings such as the Labeling Committee to seek endorsement.
Provide advice and guidance on labeling content, processes, timelines, and scientific integrity; coordinate resolution of any labeling issues with potential impact on primary or derived labeling; ensure high‑quality, compliant documents.
Contribute to continuous improvement of the end‑to‑end labeling process.
Support global labeling inspections and audits for assigned products, as applicable.
Collaborate with external partners.
Qualifications Minimum Bachelor’s degree in a scientific discipline; advanced degree (Master’s, PhD, PharmD) preferred.
Minimum 8 years of professional work experience.
Minimum 6 years of direct regulatory labeling content experience developing and writing labeling for pharmaceutical products or equivalent.
Direct experience with target labeling development or New Molecular Entity (NME) submissions preferred.
Relevant experience in the pharmaceutical industry (e.g., Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc.).
Understanding of pharmaceutical drug development.
Experience discussing and communicating scientific concepts.
Good understanding of worldwide regulatory guidelines applicable for labeling guidance.
Experience leading project teams in a matrix environment.
Experience leading continuous improvement projects.
Experience working with document management systems.
Ability to prioritize and manage multiple products and projects simultaneously (preferred).
Exceptional verbal and written communication skills.
Strong organizational, negotiation, and partnering skills.
Ability to work independently.
Ability to manage compounds with a certain degree of labeling complexity (preferred).
Ability to drive a collaborative, customer‑focused, learning culture (preferred).
Preferred Skills Analytical Reasoning
Business Writing
Fact‑Based Decision Making
Industry Analysis
Legal Support
Mentorship
Organizing
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Risk Assessments
Risk Compliance
Strategic Thinking
Technical Credibility
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