Entry Level
il y a 1 jour
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. 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.
**Entry-level positions with CDI are available for recent graduates.**
Responsibilities:
- 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 (preferably in a Life Sciences field);
- Hands-on experience preparing, reviewing, and submitting regulatory documentation;
- Good level in English and French in written and verbal communication
- Knowledge of Microsoft® Office; and
- Excellent organization and communication skills, great attention to detail.
Travel: None
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?:
When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
**Perks**:
- Flexible work hours
- WFH opportunities
- Career development
- Annual salary review
- Working environment: join a motivated team in our new offices based near Lyon Part-Dieu station
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