• CLINICAL REGULATORY AFFAIRS ADVISOR STOPS

    Job Locations US-MD-Bethesda | US-AZ-Phoenix | US-MD-Rockville | US-MD-Bethesda | US-NC-Charleston | US-ND-Fargo | US-MD-Baltimore | US-NC-Charlotte
    # of Openings
    3
    Category
    Global Health
    Type
    Regular Full-Time
  • Overview

    CAMRIS International is an international development and research firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. With experience working in more than 80 countries, we combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. We apply a customized, customer-centric, cost-effective business approach to offer greater value to our clients and challenge the way things have always been done in our field.

     

    CAMRIS clients include U.S. government agencies and multilateral and private organizations. Our core practice areas include public health, agriculture and food security, economic development, education, environment, humanitarian assistance, democracy and governance, and medical research. 

     

    CAMRIS is seeking exceptional candidates to provide scientific, technical, and other professional support services to assist the National Institutes of Health (NIH-- which is comprised of the Office of the Director and 27 Institutes and Centers) in meeting its operational objectives. Note: The positions are contigent on contract award.

    Responsibilities

    • Advises on and coordinates the approval and registration of pharmaceuticals, chemicals, therapeutics, etc.
    • Oversees the regulation process for the program.
    • Ensures that the program adheres to standard operating procedures, good clinical practices and FDA regulations.
    • Develops procedures to ensure regulatory compliance.
    • Advises scientists on regulatory requirements.
    • Over- sees the filing of all necessary applications.
    • Serves as liaison for all Government interactions. 
    • Leads and directs the work of others.

     

     

    Qualifications

    • 10-17+ years of experience in a related field. Demonstrates expertise in a variety of the field’s concepts, practices, and procedures.

       

      Minimum Education:

       

      Ph.D. in a related field. Three (3) years of specialized experience plus a Master’s degree is equivalent to a Ph.D. Five (5) years of specialized experience plus a Bachelor’s degree is equivalent to a Ph.D.

     

     

     

    This effort is for a bid and contingent on award.

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