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 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 PPD and client SOPs, directives and current regulatory guidelines

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

Remote Associate jobs in Brazil

Country Approval Associate

Country Approval Associate

Country Approval Associate

Senior Associate, Pharmacovigilance

Study Start Up Associate I

Study Start Up Associate II

Study Start Up Associate II

Study Start Up Associate II

Study Start Up Associate II

Owner Success Associate