Senior Manager, Global Labeling Product Leader

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Manager, Global Labeling Product Leader. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland.

The Senior Manager, Global Labeling Product Leader is a leading expert individual contributor who is viewed as a valuable resource by peers and manages large projects or processes. This individual will develop methods for planning, directing, coordinating and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies. Ensure compliance with regulatory agency regulations and interpretations accounting for new and changing government regulations.

The Senior Manager, Global Labeling Product Leader will be responsible for the following:

• 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.

Qualifications:

• 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.

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

Hybrid Work