Country Approval Associate

**Work Schedule**Other**Environmental Conditions**OfficeEssential Functions- Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.- Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global submission strategy.- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions 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 have contact with investigators for submission related activities.- May act as a key-contact at country level for either Ethical or Regulatory submission-related activities.- Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.- Assists in developing country specific Patient Information Sheet/Informed Consent form documents.- Assists with grant budgets(s) and payment schedules negotiations with sites.- Enters and maintains trial status information relating to SIA activities onto PPD, or client (where contracted) 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 understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.