Country Approval Specialist

• 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 activities
• Coordinate with internal functional departments on site start-up activities, submission alignment, and timelines
• Ensure submission processes for sites and studies align with 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 needed
• 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 client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives, and applicable regulatory guidelines
• Work is performed in an office/laboratory and/or clinical environment, with possible exposure to biological fluids, infectious organisms, electrical office equipment, and required personal protective equipment

• 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 the 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
• In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient