Essential Functions and Other Job Information:
- Essential
- 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 develo...