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
• Communicate with investigators regarding submission-related activities
• Serve as country-level key contact for ethical or regulatory submission activities
• Coordinate with internal functional departments to align site start-up activities and submission timelines
• Achieve target cycle times for site activities
• Work with start-up CRAs to prepare regulatory compliance review packages, as applicable
• Develop country-specific Patient Information Sheets and Informed Consent Form documents
• 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 tracking databases
• Prepare, set up and maintain local country study files and filing processes
• Maintain knowledge of PPD and client SOPs/directives and current 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
• Equivalency may be considered through a combination of appropriate education, training and/or directly related experience
• 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 under office/laboratory and/or clinical environmental conditions, including potential exposure to biological fluids and infectious organisms
• Ability to use required personal protective equipment, including protective eyewear, garments and gloves

• Fully Remote work arrangement
• Standard Monday–Friday work schedule