Ctry Approval Assoc

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 developing country specific Patient Informati...