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
