Associate

• Prepare, review and coordinate Country Submissions under guidance and in alignment with global submission strategy
• Support preparation of local Ministry of Health submissions
• Coordinate internal functional departments and site start-up activities with 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 country-level key contact for ethical or regulatory submission activities
• Prepare regulatory compliance review packages with start-up CRAs
• Develop country-specific Patient Information Sheet/Informed Consent documents
• 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 PPD and client SOPs, directives and applicable regulatory guidelines

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

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