Medpace is a leading full-service clinical Contract Research Organization (CRO) specializing in Phase I-IV clinical trials across biotechnology, pharmaceutical, and medical device industries. With over 30 years of experience, we accelerate the development of safe and effective medical treatments worldwide. Headquartered in Cincinnati, Ohio, Medpace employs 5,000+ professionals across 40+ countries, offering expertise in oncology, cardiology, metabolic diseases, CNS, and infectious diseases.
Why Join Medpace?
✅ Impactful Work – Contribute to life-saving clinical research
✅ Career Growth – Structured career paths with global exposure
✅ Award-Winning Culture – Recognized by Forbes as one of America’s Most Successful Midsize Companies (2021-2024)
✅ Employee Benefits – Competitive salary, flexible work options, wellness programs, and company-sponsored events
Job Description
Key Responsibilities:
✔ Prepare, review, and submit regulatory documents to Ethics Committees (EC) & Regulatory Authorities
✔ Ensure compliance with ICH-GCP guidelines and local regulatory requirements
✔ Communicate with global study teams and investigative sites for smooth site activation
✔ Track submissions and maintain documentation for audit readiness
✔ Provide regulatory expertise to sponsors on evolving compliance standards
✔ Identify risks in site activation and implement mitigation strategies
Qualifications & Skills:
✔ Bachelor’s degree in Life Sciences or related field
✔ 1+ years of experience in regulatory submissions, site activation, or clinical operations (CRO/pharma/site experience preferred)
✔ Strong knowledge of Microsoft Office, ICH-GCP, and regulatory guidelines
✔ Excellent communication, organizational, and problem-solving skills
✔ Fluency in English (written & verbal)
