FSP Country Approval Specialist II

• Prepare, review and coordinate local regulatory submissions, including Ministry of Health, Ethics Committee and applicable special national applications, 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
• Communicate with investigators regarding submission-related activities when required
• Serve as the country-level key contact for ethical or regulatory submission activities
• 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 PPD target cycle times for sites
• Work with start-up CRAs to prepare regulatory compliance review packages when applicable
• Develop country-specific Patient Information Sheets/Informed Consent forms when required
• Assist with grant budgets and payment schedule negotiations with sites
• Support feasibility activity coordination in accordance with 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 current applicable regulatory guidelines

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 2+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalent 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 work around biological fluids and potentially infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments and gloves

• Fully remote work mode
• Standard Monday–Friday work schedule