Talent.com
Esta oferta de trabajo no está disponible en tu país.
Country Approval Specialist

Country Approval Specialist

Thermo Fisher ScientificMexico
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

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.