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Job Details

Regulatory Submissions Coordinator - Entry Level

Company: Medpace
Location:
Reference: FRRSC1118
Closing Date: 23 Dec 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Medpace is looking for a Regulatory Submissions Coordinator - Entry level, to join our team in Lyon, France

Requirements:

Regulatory Submissions Coordinator - Entry Level

Location: Lyon, France

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Job Summary

Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator/Start up Specialist to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. 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

  • Distribute, track, review, and approve individual site Trial Master File (TMF) essential documentation at project start; 
  • Collect, review, organize, and assemble regulatory start-up submissions; 
  • Maintain timelines for regulatory submissions and site start-up; 
  • Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements; 
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges; 
  • Utilize and assist in maintaining ClinTrak® (e.g., Essential Documents module); 
  • Work with Document Center to ensure necessary documentation is present; and 
  • Train and assist Clinical Research Associates on collection of essential documentation for on-going phase of project. Review documentation submitted by Clinical Research Associates and forward to client/Document Center.

Qualifications

Duties are performed with close supervision and guidance from supervisor. The employee should begin to develop a basic understanding of clinical research and study start-up.

  • Bachelor’s degree; 
  • Proficient knowledge of Microsoft® Office software and Adobe® Acrobat; 
  • Demonstrate time management and professional oral and written communication skills;  
  • Demonstrated ability to think critically, independently, and exercise good judgement.

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. 

 

Awards

  • Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
  • Winner of the ACRP-Avoca CRO Quality Award in 2018
  • Recognized with six CRO Leadership Awards from Life Science Leader magazine
  • Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships

 

What to Expect Next

We look forward to receiving your application.  A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

Apply for this job: Regulatory Submissions Coordinator - Entry Level

Contact Information:

Address:  Medpace France
235 cours Lafayette 69006 Lyon France

France
Website:  Visit Our Web Site

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