Entry Level - Regulatory Submissions Coordinator

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position plays a key role inthe clinical trial managementprocess at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Entry-level positions with CDI are available for recent graduates.

• Prepare, review, and file clinical trial applications for France;
• Communicate with research sites in France (hospitals, etc.) to collect all essential documents required before the site starts to enrol patients to participate in the clinical trial
• Provide insightful input on regulatory submissions documents and maintain timelines for study start-up through both internal and external collaboration;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise on changing country regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.

• Bachelor's degree (preferably in a Life Sciences field);
• Hands-on experience preparing, reviewing, and submitting regulatory documentation;
• Good level in English and French in written and verbal communication
• Knowledge of Microsoft® Office; and
• Excellent organization and communication skills,great attention to detail.

Travel: None