The role
0301Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
02Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
03Provides project specific local SIA services and coordination of these projects.
04May have contact with investigators for submission related activities.
05Key-contact at country level for either Ethical or Regulatory submission-related activities.
06Coordinates, 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.
07Achieves PPD’s target cycle times for site.
08May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
09May develop country specific Patient Information Sheet/Informed Consent form documents.
10May assist with grant budgets(s) and payment schedules negotiations with sites.
11Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
12Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
13Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
14Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
