AI Developer

Position: AI Developer
Location: Short Hills, NJ

Key Responsibilities:

• Drive labeling strategy within early development activities to ensure alignment with claims development programs.
• Collaborate with Global Regulatory Team Leader to align labeling strategy with overall regulatory, registration, commercial, and development strategies.
• Serve as primary contact for cross-functional Labeling Team Members and interface for Country Regulatory Managers to support timely and quality submissions globally.
• Contribute labeling perspective to Clinical Study designs, protocols, Investigator Brochures, and Briefing Books.
• Coordinate labeling activities of multifunctional contributors, reviewers, and approvers to maximize speed and quality.
• Ensure effective planning of all cross-functional labeling activities.
• Review country labels to ensure compliance and adequacy to regulatory strategy.
• Train and provide guidance for other Global Labeling Leads as needed.
• Participate in/Lead key initiatives (Process Improvements, Development of new tools, technologies) to support efficient global label development and worldwide submissions and approvals.
• Identify opportunities to influence regulatory policy and climate with respect to labeling content.

Requirements:

• Master of Life Sciences or equivalent, with thorough understanding of scientific principles and at least 5 years of Labeling Experience (CCDS / USPI / SmPC); or Bachelor of Life Sciences and at least 7 years of Labeling / Regulatory Experience.
• Knowledge of Global Labeling Guidances, Drug Development, and Commercialization of prescription medicines.
• Understanding of the dynamics and purpose of Company Core Data Sheets (CCDS) and the implications.
• Previous experience with Health Authorities bodies.
• Proven understanding of the dynamics and purpose of the Target Product Labeling and Company Core Data Sheets (CCDS) and their implications.
• Experience in developing Target Product Labeling.
• Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling.
• Ability to develop strong and positive working relationships across diverse teams and within a global environment.
• Ability to influence and lead a diverse group of Subject Matter Experts and facilitate discussions and decision-making.
• Experience in managing high to medium complex projects.
• Excellent project management, verbal, and written communication skills.
• Keen attention to detail and accuracy, coupled with the ability to think strategically.
• Ability to assimilate clinical and scientific information and present it concisely, translating them into labeling content.
• Ability to think creatively and excellent problem-solving skills.
• Time management skills.