Essential Functions and Other Job Information:EssentialFunctions- Prepares, reviews and coordinates, under guidance and local EC submissions inalignment with global submission strategy.
- Supports preparation, under guidance, of local MoH submissions, as applicable inalignment with global submission strategy.
- Coordinates, under guidance, with internal functional departments to ensurevarious site start-up activities are aligned with submissions activities andmutually agreed upon timelines; ensures alignment of submission process forsites 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 Regulatorysubmission-related activities.
- Works with the start-up CRA(s) to prepare the regulatory compliance reviewpackages, as applicable.
- Assists in developing country s...