Closing Date: 27 Oct 16
Type: Full Time
Salary (£): Competitive
Medpace is seeking a Regulatory Submissions Coordinator for our office in Madrid.
Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 45 countries across the globe. We continue to steadily grow and are looking to add to our team!
Our clinical 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 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.
DESCRIPTION OF JOB DUTIES
• Prepare, review, submit and file clinical trial applications to national ethics committees and regulatory agencies;
• Provide updated forecast of local submission and approval timelines;
• Ensure submissions comply with applicable regulations and guidance documents;
• Collect the required investigator and regulatory documents from the sites ensuring documents meet the required specifications
• Advise study team on changing regulations and compliance requirements; and
• Track submissions and ensure timely filing of documents.
• Bachelor's degree in life sciences;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation and contracts;
• At least two years of startup experience as a Regulatory Submissions Coordinator;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office;
• Fluency in English.
At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.
WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
5375 Medpace Way
|Tel:||+1 513 579 9911|
|Fax:||+1 513 579 0444|
|Website:||Visit Our Web Site|
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