Country Approval Associate

• Prepare, review, and coordinate country and local Ethics Committee 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 to align site start-up activities and submission timelines
• Ensure submission processes align with the critical path for site activation
• Achieve company target cycle times for site activities
• Contact investigators for submission-related activities as needed
• Act as a 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 budget and payment schedule negotiations with sites
• Enter and maintain trial status information in company or client tracking databases
• Prepare, set up, and maintain local country study files and filing processes
• Maintain knowledge of company and client SOPs, directives, and applicable regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 0 to 2 years of previous relevant experience
• 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
• Basic organizational and planning skills
• Basic knowledge of applicable regional/national regulatory guidelines and EC regulations
• Appropriate education, training, and/or directly related experience may be considered as an equivalency

• Fully remote work mode
• Standard Monday-Friday work schedule
• Collaboration and development opportunities
• Exposure to a global team environment
• Personal protective equipment provided/required for applicable work