Participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy
Job Summary
Participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy.
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable).
Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
Matching Summary
Participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy.
Skills & Requirements
Must-have
Coordinate local regulatory submissions
Align with global submission strategy
Liaise with internal departments
Maintain trial status information
Understand PPD SOPs and client SOPs
Nice-to-have
Provide local regulatory strategy advice
Contact investigators for submission activities
Develop country specific patient information sheets