Regulatory Data Specialist - Entry Level Job Locations United States-OH-Cincinnati Category Biostatistics Job Summary Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Data Specialist to join our Biostatistics team. 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 Create Data Submission Package including define.xml documents and related submission documents for SDTM and ADaM datasets for all regulatory submission; Conformance of Data Submission documents compliant to all specifications and guidelines outlined by the Clinical Data Interchange Standards Consortium (CDISC) and specific electronic data submission guidelines; and Provide support and assistance to Data Standard Analysts, Statistical Analysts, Biostatistician, and others as needed regarding data submissions. Qualifications Bachelors degree in Math, Statistics, Computer Science, Life Science, or related area Experience with Microsoft Excel and Word Experience with Adobe Attention to detail and time management skills TRAVEL: None 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 5,000 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. Cincinnati Perks Cincinnati Campus Overview Hybrid work-from-home options (dependent upon position and level) Competitive PTO packages, starting at 20+ days Competitive compensation and benefits package Flexible work schedule Company-sponsored employee appreciation events Employee health and wellness initiatives Community involvement with local nonprofit organizations Discounts on local sports games, fitness gyms and attractions Modern, ecofriendly campus with an on-site fitness center Structured career paths with opportunities for professional growth Discounted tuition for UC online programs 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