Country Approval Associate

• Prepare, review, and coordinate local regulatory submissions in alignment with the global submission strategy
• Provide local regulatory strategy advice to internal clients under guidance
• Provide and coordinate project-specific local SIA services
• Contact investigators for submission-related activities as needed
• Serve as the country-level key contact for ethical or regulatory submission-related activities
• Coordinate with internal functional departments to align site start-up activities, submission activities, timelines, and the critical path for site activation
• Achieve PPD target cycle times for sites
• Work with start-up CRAs to prepare regulatory compliance review packages, as applicable
• Develop country-specific Patient Information Sheets/Informed Consent forms, as applicable
• Assist with grant budgets and payment schedule negotiations with sites
• Support feasibility activities according to agreed timelines
• Enter and maintain trial status information for SIA activities in PPD tracking databases
• Prepare, set up, 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 applicable 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 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 all applicable regional/national country regulatory guidelines and EC regulations
• Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
• Ability to work in an office/laboratory and/or clinical environment
• Ability to work with potential exposure to biological fluids, infectious organisms, and electrical office equipment
• Personal protective equipment required, including protective eyewear, garments and gloves