Entry Level - Regulatory Submissions Coordinator

Medpace; France; Sur place; EUR 35 000 - 45 000; Plein temps

Résumé du poste

A clinical research company is seeking a full-time Regulatory Submissions Coordinator in Lyon. The role involves preparing and submitting clinical trial applications, ensuring compliance with regulatory requirements, and collaborating with research sites. Candidates should have a Bachelor's degree in Life Sciences and good communication skills in English and French. This entry-level position offers opportunities for career growth in a flexible work environment.

Prestations

Flexible work environment

Competitive compensation and benefits package

Career growth opportunities

Employee appreciation events

Health and wellness initiatives

Qualifications

• Bachelor's degree in a relevant field required.
• Good level in English and French communication.
• Detail-oriented and organized.

Responsabilités

• Prepare, review, and file clinical trial applications for France.
• Communicate with research sites to collect essential documents.
• Ensure compliance with regulatory requirements.

Connaissances

Attention to detail

Communication skills

Microsoft Office

Written and verbal communication in English and French

Formation

Bachelor's degree in a Life Sciences field

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.

Entry-level positions available for recent graduates.

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.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America\'s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.