FSP Country Approval Associate
Core
Prepare, review, and coordinate country submissions for clinical trial site activations in alignment with global strategy.
Role type
Associate, clinical trial regulatory submissions
Builds
Site start-up activities and regulatory compliance packages
Domain
Clinical trials / Regulatory affairs
Required skills
Regulatory guidelines knowledge, submission coordination, document preparation, database management, negotiation, medical terminology
Preferred skills
None stated
Technologies
Tracking databases, office software
Responsibilities
Prepare and review local EC and MoH submissions, coordinate site start-up activities, maintain trial status information, assist with patient information sheets and grant budgets, ensure alignment with global submission strategy
Seniority
Junior, 0-2 years experience
