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Short Hills

    AI Developer - Short Hills, United States - Compu-Vision Consulting, Inc.

    Compu-Vision Consulting, Inc.
    Compu-Vision Consulting, Inc. Short Hills, United States

    3 weeks ago

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    Description

    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.
    AI Developer -AID
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