Experienced Regulatory Submissions Coordinator

Job SummaryOur 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.ResponsibilitiesProvide 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 applicationsCommunicate 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.QualificationsBachelor'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 OverviewMedpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including

oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.Why Medpace?When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional WorkWork alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellenceCollaborative CultureContribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.Leadership throughout Medpace is both accessible and approachableContinuous Growth & DevelopmentOffice based environment with on-site