Johnson & Johnson is seeking an Associate Director, Global Labeling Product Leader to drive the global labeling strategy and ensure compliance with regulatory guidelines for pharmaceutical products.
Requirements
- A minimum of 6 years of direct regulatory labeling content experience developing and writing labeling content for pharmaceutical products or equivalent is required.
- Direct experience with target labeling development or New Molecular Entity (NME) submissions is preferred.
- 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.
- 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 working with document management systems is required.
Responsibilities
- Drive the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area, their development plans and status and knowledge of labeling aspects for labeling development and target labeling for new products.
- Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety, market access, commercial, medical affairs) to ensure the global labeling strategy aligns with the Global Regulatory and Product Strategy for assigned products.
- 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), with a label-as-driver approach.
- Provide strategic labeling advice for local labeling in major markets.
- Analyze relevant competitor labeling, leverage labeling guidance and trends to develop labeling strategy and content, including risk and mitigation identification and assessment.
- Lead Health Authority (HA) labeling strategy discussions and development of contingency labeling plans and content.
Other
- 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.
- Must have exceptional verbal and written communication skills.
- Must have strong organizational, negotiation, and partnering skills.
- Must have the ability to work independently.
