[Next-Generation Sequencing Book]
  • [Photo] Jessica Cartmel • December 23, 2008

    BACKGROUND

    Schering-Plough is an innovation-driven, science-centered global health care company. Through our own biopharmaceutical research and collaborations with partners, we create therapies that help save and improve lives around the world. We apply our research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by our colleagues around the world.

    RESPONSIBILITIES

    Global Clinical Audits Senior Auditor independently performs or leads all types of audits to assess quality level and compliance with applicable GCP regulations. Communicates audit findings and recommendations for corrective actions to clients on all levels and evaluates adequacy and completeness of corrective action plans.

    Reviews audit reports prior to issuance to clients for accuracy and consistency and provides guidance to auditors in communicating findings and recommendations. Evaluates audit report findings for identification of trends. Participates in evaluation of effectiveness of the audit program applied to specific projects.
    • Applies advanced technical skills in compliance with Good Clinical Practices related to clinical research.
    • Participates in development of written procedures for the unit.
    • Participates in development and training of new audit staff.
    • Participates in development of quality improvement strategies and tools for the client groups.

    REQUIREMENTS

    BA/BS in the life sciences and 8 years relevant industry experience with 5 years experience in the GCP - regulated environment or equivalent. or Advanced degree with 5 years of relevant industry experience and 4 years of experience in the GCP - regulated environment or equivalent. and Must be willing to travel approximately 20-30%.

    Must have a thorough understanding of GCP regulations and standards for interpretation of audit findings, the impact and implications. Computer skills and understanding are necessary. Excellent written and verbal communication skills are required. Appropriate technical skills in GCP compliance are necessary.

    LOCALE: Kenilworth, NJ

    SALARY & COMPENSATION: Commensurate

    HOW TO APPLY

    Please copy and paste the following link into your browser address bar:
    http://appclix.postmasterlx.com/track.html?pid=402881bd1e48ea6f011e4b9cc7c9067f&source=bioinformatics

    ARTICLE: Req. Number: 23429BR

    Schering-Plough is an equal opportunity employer. M/F/D/V

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