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Global Compliance Coordinator

2 meses atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

Job Summary

Thermo Fisher Scientific is seeking a highly skilled Country Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for preparing, reviewing, and coordinating local regulatory submissions in alignment with our global submission strategy.

Key Responsibilities

  • Regulatory Submission Coordination
    • Prepare, review, and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable) in alignment with global submission strategy.
  • Regulatory Strategy Advice
    • Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Project Coordination
    • Provide project specific local SIA services and coordination of these projects.
  • Communication and Collaboration
    • May have contact with investigators for submission related activities.
    • Key-contact at country level for either Ethical or Regulatory submission-related activities.
  • Process Alignment
    • Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
  • Performance Metrics
    • Achieves PPD's target cycle times for site.
  • Regulatory Compliance
    • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
    • May develop country specific Patient Information Sheet/Informed Consent form documents.
  • Reporting and Record Keeping
    • Enters and maintains trial status information relating to SIA activities onto PPD 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.
  • Knowledge and Compliance
    • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Requirements

  • Strong understanding of local regulatory requirements and guidelines.
  • Excellent communication and collaboration skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.
  • Strong analytical and problem-solving skills.
  • Proficiency in Microsoft Office and ability to learn new software applications.