Country Approval Specialist

hace 1 semana


Xico, México Thermo Fisher Scientific A tiempo completo
Job Summary

Thermo Fisher Scientific is seeking a highly skilled Country Approval Specialist to join our team. As a key member of our regulatory compliance team, you will be responsible for ensuring the smooth execution of clinical trials in various countries.

Key Responsibilities
  • Submission Preparation: Prepare, review, and coordinate local EC submissions in alignment with our global submission strategy.
  • Local MoH Submissions: Support the preparation of local MoH submissions, as applicable, in alignment with our global submission strategy.
  • Site Activation: Coordinate with internal functional departments to ensure site start-up activities are aligned with submissions activities and mutually agreed-upon timelines.
  • Regulatory Compliance: Work with the start-up CRA(s) to prepare regulatory compliance review packages, as applicable.
  • Country-Specific Documents: Assist in developing country-specific Patient Information Sheet/Informed Consent form documents.
  • Grant Budgets and Payments: Assist with grant budgets and payment schedules negotiations with sites.
  • Database Management: Enter and maintain trial status information relating to SIA activities onto PPD or client (where contracted) tracking databases in an accurate and timely manner.
  • Country Study Files: Ensure the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
  • Knowledge and Understanding: Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Requirements

To be successful in this role, you will need to have a strong understanding of regulatory compliance and clinical trial operations. You will also need to be highly organized, with excellent communication and project management skills.


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