Study Start Up - 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 use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Entry-level positions are available for recent graduates. Responsibilities Prepare, review, and file clinical trial applications for UK & Ireland; Provide insightful input on regulatory submissions documents and timelines; Ensure submissions comply with applicable regulations and guidance documents; Advise on changing country regulations and compliance requirements; and Track submissions and ensure timely filing of documents. Qualifications Bachelor's degree (preferably in a Life Sciences field); Experience in study start-up - desirable; Hands-on experience preparing, reviewing, and submitting regulatory documentation is beneficial; Knowledge of Microsoft Office; and 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 4,000 people across almost 40 countries. 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 Hybrid work-from-home options (dependent upon position and level) Competitive PTO packages Company-sponsored employee appreciation events Employee health and wellness initiatives Flexible work schedule Competitive compensation and benefits package Structured career paths with opportunities for professional growth 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. EO/AA Employer M/F/Disability/Vets