Country Approval 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 activities align with the critical path for site activation
• Achieve company target cycle times for sites
• Contact investigators regarding 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 and 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
• Ability to work in an office/laboratory and/or clinical environment
• Ability to comply with biological-fluid exposure controls and use required personal protective equipment

• Collaboration and development opportunities
• Work in a global team environment
• Exposure to scientific innovation and meaningful contributions