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, where applicable
• Coordinate with internal functional departments to align site start-up activities with submission activities and agreed timelines
• Ensure submission processes for sites and studies align with the critical path for site activation
• Achieve company target cycle times for site activities
• Contact investigators regarding 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 budgets and payment schedule negotiations with sites
• Enter and maintain trial status information for SIA activities in company or client tracking databases
• Prepare, establish and maintain local country study files and filing processes according to PPD WPDs or applicable client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 2 years
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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 handle potential exposure to biological fluids, infectious organisms and electrical office equipment
• Ability to use required personal protective equipment

• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused workplace
• Personal protective equipment provided/required, including protective eyewear, garments and gloves