About this role
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;
- 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
We kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.
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.
About Medpace
Full-service contract research organization providing clinical development services across therapeutic areas. Headquartered in Cincinnati, OH.
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