Experienced Regulatory Submissions Coordinator
Job Description
Job Summary
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.
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;
- Perform other tasks as needed;
- Prepare, review, and file clinical trial applications;
- Communicate with research sites (hospitals, etc.) to collect all essential documents required before the site starts to enrol 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.
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.
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.
