SSU II/CAS

Country Approval Specialist responsible for supporting study startup by coordinating local regulatory submissions (MoH, EC, and other national/local applications) in line with global submission strategy. Provides local regulatory strategy advice to internal clients, coordinates startup activities, may contact investigators for submission-related activities, serves as key country contact for ethical/regulatory submission activities, ensures site activation aligns with submission timelines, and maintains trial status information. Requires coordinating with internal departments, developing country-specific documents (e.g., patient information sheets/informed consent forms), assisting with grant budgets and site payments, and staying updated on local regulatory guidelines and EC regulations. Bachelor’s degree and ~2+ years of relevant experience are expected; strong communication, negotiation, and computer skills are essential, with proficiency in English and ability to work in teams or independently. Travel may be required; office-based role with standard hours. The position sits within Thermo Fisher Scientific / PPD’s clinical research services focused on end-to-end study startup support across commercial and government contracts.