Associate

• Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy
• Support preparation of local Ministry of Health submissions, as applicable
• Coordinate with internal functional departments on site start-up activities and submission timelines
• Ensure submission processes align with the critical path for site activation
• Achieve company target cycle times for sites
• Contact investigators for submission-related activities as needed
• Act as a country-level key contact for Ethical or Regulatory submission activities
• Work with start-up CRAs to prepare regulatory compliance review packages
• Assist in developing country-specific Patient Information Sheets and Informed Consent Forms
• Assist with grant budgets and payment schedule negotiations with sites
• Enter and maintain trial status information in tracking databases
• Prepare, set up and maintain local country study files and filing processes
• Maintain knowledge of company and client SOPs, directives and current regulatory guidelines

Explore Country Approval Associate at Thermo Fisher Scientific. Review requirements and application details.

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