Work Schedule

Environmental Conditions

Job Description

- Prepares, reviews and coordinates local regulatory submissions (MoH, EC and additional special national local applications as applicable) in alignment with the global submission strategy.

- Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines.

- Ensures the submission process for sites and studies are aligned to the critical path for site activation. - Maintains contact with investigators for submission related activities;

- Serves as key-contact at country level for either Ethical or Regulatory submission-related activities.

- 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.

- May supports the coordination of feasibility activities, as required, in accordance with agreed timelines.