Ctry Approval Assoc

Job Description

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 PPDâs 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 Information Sheet/Informed 
Consent form documents.
⢠Assists with grant budgets(s) and payment schedules negotiations with sites.
⢠Enters and maintains trial status information relating to SIA activities onto PPD, 
or client (where contracted) tracking databases in an accurate and timely 
manner
⢠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.