Regulatory Submissions (Study Start-up) Coordinator
Our clinical activities are growing rapidly, and we are currently seeking a full-time home-based Regulatory Submissions Coordinator. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. 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.
Responsibilities
Prepare, review, and file clinical trial applications to domestic regulatory agencies; Prepare and submit responses to queries and amendments to clinical trial applications; Ensure submissions comply with applicable regulations and guidance documents; Advise sponsors and internal stakeholders on changing regulations and compliance requirements; Track submissions and ensure timely filing of documents.
Qualifications
Minimum Bachelor's degree in life sciences; At least one year of work experience as a Regulatory Submissions Coordinator for European regulation (CTR); Excellent organization and communication skills; Knowledge of Microsoft® Office; Hands-on experience preparing, reviewing, and submitting regulatory documentation; and Greek (mother tongue) and very good knowledge of English. 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. 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.