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    Ctry Approval Assoc - Mexico City, México - Thermo Fisher Scientific

    Thermo Fisher Scientific
    Thermo Fisher Scientific Mexico City, México

    hace 2 semanas

    Thermo Fisher Scientific background
    De jornada completa
    Descripción
    Essential Functions and

    Other Job Information:
    Essential
    Functions


    • Prepares, reviews and coordinates, under guidance and local EC submissions in
    alignment with global submission strategy.


    • Supports preparation, under guidance, of local MoH submissions, as applicable in
    alignment with global submission strategy.


    • Coordinates, under guidance, with internal functional departments to ensure
    various site start-up activities are aligned with submissions activities and
    mutually agreed upon timelines; ensures alignment of submission process for
    sites and study are aligned to the critical path for site activation.


    • Achieves PPD's target cycle times for site.
    • May have contact with investigators for submission related activities.
    • May act as a key-contact at country level for either Ethical or Regulatory
    submission-related activities.


    • Works with the start-up CRA(s) to prepare the regulatory compliance review
    packages, as applicable.


    • Assists in developing country specific Patient Information Sheet/Informed
    Consent form documents.


    • Assists with grant budgets(s) and payment schedules negotiations with sites.
    • Enters and maintains trial status information relating to SIA activities onto PPD,
    or client (where contracted) tracking databases in an accurate and timely
    manner


    • Ensures the local country study files and filing processes are prepared, set up
    and maintained as per PPD WPDs or applicable client SOPs.


    • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and
    current regulatory guidelines as applicable to services provided.
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