FSP Bench Country Approval Specialist

Overview

Supports the preparation, review, coordination, and management of country-level regulatory and ethics submissions for clinical studies in Colombia.

What you'll do

• Prepare, review, and coordinate local regulatory submissions under guidance.
• Provide local regulatory strategy advice to internal clients.
• Coordinate site start-up activities with internal functional departments.
• Act as the country contact for ethics or regulatory submission activities.
• Maintain trial status information in tracking databases.
• Prepare and maintain country study files and filing processes.
• Support feasibility activities and regulatory compliance review packages.

What you'll need

• At least 2 years of comparable experience.
• Bachelor's degree or equivalent formal academic or vocational qualification.
• Effective oral and written communication skills.
• Strong attention to detail and documentation quality.
• Basic knowledge of applicable national regulatory guidelines and ethics committee regulations.
• Good English language and grammar skills.
• Ability to work independently or in a team under direction.

Details

• Remote work in Colombia.
• Standard Monday-Friday work schedule.