Country Approval Associate

Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation

The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:

• Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy.
• Support preparation, under guidance, of local MoH submissions, as applicable in alignment with general submission strategy.
• Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieve company’s target cycle times for site.
• May have contact with investigators for submission related ...