Experienced Study Start Up Coordinator

Medpace; Lyon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A leading clinical research organization in Lyon is seeking a full-time Regulatory Submissions Coordinator to join their Clinical Operations team. This position is crucial for managing clinical trial submissions in compliance with regulations. The ideal candidate will possess a Bachelor's degree in Life Sciences, have 4-5 years of relevant experience, and be fully proficient in both French and English. You will prepare and review submissions, and ensure regulatory compliance while maintaining excellent organizational and communication skills.

Qualifications

• Bachelor's degree (preferably in a Life Sciences field) required.
• 4-5 years of experience as a Regulatory Submissions Coordinator needed.
• Hands-on experience with regulatory documentation is necessary.

Responsabilités

• Prepare and file clinical trial applications for France.
• Submit responses to queries and amendments for applications.
• Advise team on changing regulations and compliance requirements.

Connaissances

Regulatory documentation preparation

Bilingual in French and English

Organization skills

Attention to detail

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 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;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise team members on changing regulations and compliance requirements;
• Maintain the Clinical Trial Management System and ensure timely filing of documents;
• Collect essential documents and prepare essential documents packages for drug release.

Qualifications

• A minimum of a Bachelor's degree (preferably in a Life Sciences field);
• At least 4‑5 years of work experience as a Regulatory Submissions Coordinator;
• Hands‑on experience preparing, reviewing, and submitting regulatory documentation;
• Full professional proficiency in French and English in written and verbal communication;
• Knowledge of Microsoft Office;
• Excellent organization and communication skills, great attention to detail.

Travel: Minimal