Country Approval Specialist

Country Approval Specialist – PPD PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose — to improve health. Site and Patient Access is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry‑leading cycle times. Working in Site and Patient Access, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence. As a Country Approval Specialist, you are responsible for pulling regulatory country submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable. Responsibilities Provides, under guidance, local regulatory strategy advice (MoH & or EC) to internal clients Provides project-specific local SIA services and coordinates these projects May have contact with investigators for submission‑related activities Key contact at country level for either ethical or regulatory submission‑related activities Coordinates, under guidance, with internal functional departments to ensure various site start‑up activities are aligned with submission activities and mutually agreed‑upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation Achieves PPD’s target cycle times for site May work with the start‑up CRA(s) to prepare the regulatory compliance review packages, as applicable May develop country‑specific Patient Information Sheet / Informed Consent form documents May assist with grant budgets(s) and payment schedule negotiations with sites Supports the coordination of feasibility activities, as required, in accordance with agreed timelines Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs Maintains knowledge of and understands PPD SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided Qualifications Bachelor’s degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) Knowledge, Skills, and Abilities 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 PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Working Environment / Requirements Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner Able to work upright and stationary and/or standing for typical working hours Able to lift and move objects up to 25 pounds Able to work in non‑traditional work environments Able to use and learn standard office equipment and technology with proficiency May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments Diversity Statement PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability. 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