About the role

Country Approval Associate coordinating ethical and regulatory submissions for Thermo Fisher Scientific’s clinical-trial operations. Supporting site activation, study files, compliance packages, and country-level approvals.

Responsibilities

Prepare, review and coordinate country and local EC 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 country-level key contact for ethical or regulatory submission activities as needed
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/client SOPs, directives and current regulatory guidelines

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience comparable to 0 to 2 years
Effective oral and written communication skills
Excellent interpersonal skills
Strong attention to detail and quality of documentation
Good negotiation skills
Good computer skills and ability to learn appropriate software
Good English language and grammar skills
Basic medical/therapeutic area and medical terminology knowledge
Ability to work in a team environment or independently, under direction, as required
Basic organizational and planning skills
Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations