Regulatory Submissions Coordinator

Medpace; Lyon; Sur place; EUR 30 000 - 40 000; Plein temps

Résumé du poste

A clinical contract research organization in Lyon is seeking a full-time Regulatory Submissions Coordinator. This role is vital for managing clinical trials, involving preparation and filing of applications, site communication, and ensuring compliance with regulations. Ideal for recent graduates, it offers an opportunity to develop within the clinical operations team.

Qualifications

• Bachelor's degree in a Life Sciences field required.
• Good level in English and French needed.
• Hands-on experience with regulatory documentation is beneficial.

Responsabilités

• Prepare, review, and file clinical trial applications for France.
• Communicate with research sites to collect essential documents.
• Provide input on regulatory submissions and maintain timelines.
• Ensure submissions comply with applicable regulations.
• Track submissions and ensure timely filing.

Connaissances

Attention to detail

Good level in English

Good level in French

Organization skills

Communication skills

Formation

Bachelor's degree in Life Sciences

Outils

Microsoft Office

Description du poste

Overview

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.

Job Summary

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.