Medpace, Inc.
Experienced Regulatory Submissions Coordinator
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Regulatory Submissions Coordinator
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 can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Provide day-to-day departmental support activities to Regulatory Submissions Coordinators;
- Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities;
- Collect, review, organize, and assemble regulatory start-up submissions; and,
- Perform other tasks as needed.
Additional Responsibilities:
- Prepare, review, and file clinical trial applications
- Communicate with research sites (hospitals, etc.) to collect all essential documents required before the site starts to enroll 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.
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Qualifications
- Bachelor's degree in a Life Sciences field;
- At least 2 years of work experience as a Regulatory Submissions Coordinator;
- Hands-on experience preparing, reviewing, and submitting regulatory documentation;
- Knowledge of Microsoft® Office;
- Excellent organization and communication skills;
- Great attention to detail.
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 6,000 people across 40+ countries.
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Why Medpace?
People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.
The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Medpace Perks
- Flexible work environment
- Competitive compensation and benefits package
- Competitive PTO packages
- Structured career paths with opportunities for professional growth
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
Awards
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023, and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
What to Expect Next
A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
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