Ctry Approval Assoc

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.
- A...