Entry Level - Regulatory Submissions Coordinator

Medpace; Lyon; Sur place; EUR 35 000 - 50 000; Plein temps

Résumé du poste

A leading clinical operations firm in Lyon is seeking a Regulatory Submissions Coordinator to prepare and file clinical trial applications. The ideal candidate should have a Bachelor's degree in Life Sciences and good communication skills in English and French. This full-time role involves ensuring regulatory compliance and collaborating with research sites. A strong attention to detail is essential. Submit your CV in English.

Qualifications

• Bachelor's degree in a Life Sciences field.
• Good level in English and French in written and verbal communication.
• Hands-on experience preparing regulatory documentation is beneficial but not necessary.

Responsabilités

• Prepare, review, and file clinical trial applications for France.
• Communicate with research sites to collect essential documents.
• Maintain timelines for study start-up through collaboration.
• Ensure submissions comply with regulations.
• Advise on changing country regulations.
• Track submissions and ensure timely filing of documents.

Connaissances

Attention to detail

English communication

French communication

Organization skills

Formation

Bachelor's degree in Life Sciences

Outils

Microsoft Office

Description du poste

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 in Lyon. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your education, previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• 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.

Qualifications

• Bachelor\'s degree (in a Life Sciences field);
• Good level in English and French in written and verbal communication;
• Attention to detail;
• Knowledge of Microsoft Office;
• Excellent organization and communication skills, great attention to detail;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation is beneficial but not necessary.

Travel: None

Please submit your CV in English.