Valeant Pharmaceuticals

  • Associate Director, Regulatory Affairs - Advertising and Promotion

    Location US-NJ-Bridgewater
    Job ID
    9915
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    The Associate Director of Advertising & Promotion reviews, approves and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies requirements.

    Responsibilities

    • Provides regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies for assigned products
    • Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies
    • Monitors FDA activity (e.g. enforcement, guidance documents, etc.) to analyze and assess impact on company products
    • Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements
    • Trains regulatory staff as required
    • Monitors competitor advertising to keep abreast of market promotional and advertising strategies, and assesses potentially violative competitive materials for forwarding to OPDP as appropriate
    • Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance
    • Works closely with the RA labeling group regarding package insert changes to assure that promotional PIs and Important Safety Information are updated as appropriate

     

    Qualifications

    • Bachelors degree in science or health related discipline (Advanced degree PhD, MD, MS, PharmD preferred)
    • Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency
    • Strong capability to work in a team environment
    • Strong business acumen and the ability to see business drivers outside of regulatory affairs
    • Excellent communication skills, both oral and written
    • Strong interpersonal skills with the ability to influence others in a positive and effective manner

    • 8+ years of relevant pharmaceutical experience with 4-6+ years of relevant pharmaceutical advertising and promotion experience. Knowledge of the pharmaceutical industry regulatory affairs discipline for prescription drugs.  Demonstrated ability to contribute to a continuous learning and process improvement environment.

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