About this role
Job title: Experienced Regulatory Submissions Coordinator
About the Role The Regulatory Submissions Coordinator will support the Regulatory Submissions Coordinators within Medpace's Clinical Operations team, playing a key role in the clinical trial management process. This office-based role focuses on day-to-day start-up activities and timely regulatory submissions to enable site activation at Medpace.
What You'll Do
- 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
- Prepare, review, and file clinical trial applications
- Communicate with research sites 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
- Perform other tasks as needed
What We're Looking For
- 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
Nice to Have
Compensation & Benefits
- 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; CRO Leadership Awards from Life Science Leader magazine