AI Developer -AID24-07219 - Collaborative Environment

Position: AI Developer
Location: Short Hills, NJ
Duration: 1 Year

Overview:

The Associate Director, Global Labeling Strategy for Early Asset holds the primary accountability for the creation and updates of critical labeling documents, including Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Inserts (USPI), and EU Summary of Product Characteristics (SmPC) for products registered via centralized, Mutual Recognition, or Decentralized Procedure. This pivotal role drives the labeling strategy in alignment with regulatory, commercial, and development strategies, ensuring compliance and efficacy throughout the product lifecycle.

Key Responsibilities:

• Develop and execute labeling strategy for early development activities, integrating labeling considerations into claims development programs.
• Collaborate closely with Global Regulatory Team Leader to align labeling strategy with regulatory objectives, providing expertise in labeling regulations and competitor analyses.
• Act as the primary contact for cross-functional Labeling Team Members (CFLT), facilitating communication and coordination between various stakeholders.
• Provide labeling insights for clinical study designs, protocols, Investigator Brochures, and Briefing Books.
• Coordinate multifunctional labeling activities, managing the review and approval process to optimize efficiency and quality.
• Conduct reviews of country-specific labels to ensure compliance with regulatory standards and strategic objectives.
• Provide training and guidance to other Global Labeling Leads as necessary.
• Lead key initiatives aimed at process improvements and development of new tools and technologies to enhance global label development and submissions.
• Identify opportunities to influence regulatory policy and climate regarding labeling content.

Qualifications:

• Master's degree in Life Sciences or equivalent, with a thorough understanding of scientific principles, and a minimum of 5 years of labeling experience (CCDS/USPI/SmPC), or Bachelor's degree in Life Sciences with at least 7 years of labeling/regulatory experience.
• Comprehensive knowledge of Global Labeling Guidances, drug development, and commercialization of prescription medicines.
• Understanding of Company Core Data Sheets (CCDS) and their implications in pharmaceutical drug development.
• Previous experience engaging with Health Authorities bodies.
• Demonstrated ability to develop strong working relationships across diverse teams within a global environment.
• Proven experience in managing high to medium complex projects.
• Excellent project management, verbal, and written communication skills.
• Strong attention to detail and accuracy, coupled with strategic thinking ability.
• Proficiency in assimilating clinical and scientific information and translating it into labeling content.
• Creative thinking and strong problem-solving skills.
• Effective time management skills.

Comments for Suppliers: N/A