Experienced Study Start Up Coordinator

Medpace, Inc.; Lyon; Sur place; EUR 40 000 - 55 000; Plein temps

Résumé du poste

Medpace, Inc. is looking for a full-time Regulatory Submissions Coordinator to join our Clinical Operations team in Lyon. This role is crucial for managing the clinical trial process and involves ensuring compliance with regulatory standards.

The ideal candidate will have a Bachelor's degree in a Life Sciences field, with at least 4-5 years of relevant experience. Proficiency in both French and English, as well as strong organizational skills, are essential competencies for this position.

Qualifications

• Minimum of 4-5 years of experience as a Regulatory Submissions Coordinator.
• Hands-on experience preparing and submitting regulatory documentation.
• Full professional proficiency in French and English.

Responsabilités

• Prepare and file clinical trial applications for France.
• Ensure submissions comply with applicable regulations.
• Advise team members on changing regulations.

Connaissances

Regulatory documentation preparation

Bilingual communication (French & English)

Attention to detail

Organization and communication

Formation

Bachelor's degree in a Life Sciences field

Outils

Microsoft Office

Description du poste

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-timeoffice-basedRegulatory Submissions Coordinator to join our Clinical Operations team inLyon. 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;
• Collection of essential documents and preparation 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; and
• Excellent organization and communication skills, great attention to detail.

Travel: Minimal