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Country Approval Specialist

  • Warszawa, mazowieckie
  • Specjalista
  • 28.12.2018

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

    Country Approval Specialist

    PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

    Would you like to become part of our Site Intelligence and Activation (SIA) group in PPD Poland? Then we have an opportunity for you - join our team of global professionals as:

    The Country Approval Specialist will be responsible for obtaining Ethics and Regulatory approvals to conduct clinical studies in Poland and to ensure the activation of the sites in clinical studies.
    Main duties and Responsibilities include but are not limited to:
    • Prepare, review and coordinate local ethics and regulatory submissions in alignment with global submission strategy;
    • Act as a key contact for the study team, on a country level, for the start-up related activities and provide oversight for projects;
    • Prepare and collect the documentation required for site’s initiation in a clinical study, in collaboration with the Clinical Research Associate;
    • Provide local regulatory strategy and advice for the conduct of clinical trials;

    Ideally candidates will have regulatory and submission experience or CRA experience in clinical studies and good knowledge of all applicable national regulatory requirements. If you have excellent English skills and ability to work in a team environment and independently with minimum supervision then apply now!
    HOW TO APPLY: Please submit your CV in English. Suitable candidates will be contacted accordingly.
    PPD is an equal opportunity employer.