Country Approval Specialist

• Prepare, review and coordinate local regulatory submissions, including MoH, EC and applicable special national/local 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
• Contact investigators for submission-related activities as needed
• Serve as country-level key contact for ethical or regulatory submission-related 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, as applicable
• Develop country-specific Patient Information Sheets and 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, 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
• 2+ years of previous experience providing relevant knowledge, skills, and abilities
• 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 and Turkish 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

• Award-winning learning and development programme
• Competitive salary
• Extensive benefits package focused on employee health and well-being
• Flexible working culture
• Work-life balance
• Collaborative work environment
• Opportunities to grow professionally and personally
• Diverse and inclusive workplace valuing varied experiences, backgrounds and perspectives