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Regulatory Submissions Coordinator
Medpace Holdings, Inc.
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Graduate to join our Clinical Operations team as a Entry Level Regulatory Submissions Coordinator. This position plays a key role inthe clinical trial managementprocess 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.
- Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise sponsors on changing regulations and compliance requirements;
- Track submissions and ensure timely filing of documents;
- Collection of essential documents and preparation essential documents packages for drug release; and
- Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
• A minimum of a Bachelor's degree in Life Sciences is required; • At least one year of work experience as a Regulatory Submissions Coordinator;• Excellent organizational and prioritization skills;• Knowledge of Microsoft Office;• Hands-on experience preparing, reviewing, and submitting regulatory documentation; and• Fluency in English.
Note: Only CVs in English will be considered
Job posted: 2023-07-07