Director, Global Labeling Strategy

Global Director, Labeling Strategy

Drive Labeling Strategy, in line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CC), USPI and local labeling from early-stage development through to product maintenance. Facilitate strategic development of labeling and labeling components, by leading a diverse cross-functional subteam through discussion and decisions. Evaluate and communicate strategies and anticipate risks associated with CCDS content updates and implementation.

• Demonstrate high-level understanding of labeling content requirements, regulations, and guidance worldwide.
• Lead or contribute to cross-functional teams:
  Labeling Committees, Labeling Teams, and provide direction and support to Product Review Council teams, Legal and other groups.
• Develop and maintain Target Product Label, Company Core Data Sheet (CCDS) and local labels.
• Ensure that all labeling (for development and marketed products) is appropriately developed and maintained according to relevant laws and regulations.
• High-level understanding of the dynamics and purpose of the Target Product Label and CCDS and the associated implications on labeling globally.
• Evaluate and communicate risks associated with CCDS content updates and implementation strategies.
• Assess regional labeling to ensure compliance with CCDS.
• Assess competitor labeling—understanding precedents & opportunities.
• Assimilate key clinical, scientific, and medical information and present it concisely.
• Understand and address payer needs and commercial differentiation strategies.
• During HA reviews, continuously assess dossier review comments for labeling impact, develop alternate proposals, and negotiate strategies.
• Support global HA interaction strategy to discuss key labeling elements.
• Lead response to Health Authority (HA) questions for labeling and respond to labeling-related inquiries globally.
• Develop clear communications for senior management and SOP approvers to streamline final label negotiations and approval.
• Present to Global Labeling Review Team: ensure Core Data Sheet accurately reflects current benefit/risk profile.
• Ensure deliverables are met and labeling claims are consistent across programs.
• Develop and implement strategies to enhance global labeling awareness—use of core data sheets, strategic global mindset.
• Support all tracking, planning and storage activities related to labeling, including any computer or manual system related activities.
• Follow and formulate improvements to labeling policies, processes, quality, and system tools.
• Maintain local labels consistency with global labeling.
• Analyze and interpret new regulations and guidance, monitor impact on product labeling, identify opportunities to influence regulatory policy and climate.
• Provide strategic advice on implementing new regulations, input for promotional messages as needed.
• Contribute to continuous improvement of the end-to-end labeling process and support labeling inspection/audit readiness activities.
• Provide leadership and mentoring to team members and motivate others to innovate.
• May be assigned additional responsibilities as deemed necessary.

• BSc or advanced scientific degree (MSc, PhD or Pharm
  
  D) preferred.
• 10+ years of relevant pharmaceutical Labeling/Regulatory experience.
• Thorough understanding of scientific principals and regulatory systems relevant to drug development.
• Experience writing CCDS and USPI documents for new products.

• Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and industry practice.
• Exceptional understanding of medical concepts and terminology.
• Strong written and oral communication skills, including presentation skills.
• Considerable experience in managing high to medium complex projects.
• Strong aptitude for IT systems; preferable knowledge with RIMS and EDMS; proficiency in MS Office suite.
• Demonstrated ability to work with and manage people in a global, dynamic environment.
• Proven matrix leader with excellent problem-solving innovative solutions.
• Demonstrated ability to provide leadership and development for junior team members.
• Solid ability to…