Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, remote-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. As a Regulatory Submissions Coordinator with Medpace Canada, you will have the opportunity to work with innovative therapeutic fields with exposure to diverse, challenging studies ranging from Phases I – III.  On a day-to-day basis, you will have the opportunity to use your study start-up expertise to guide and administer internal processes, as well as advise clients on Health Canada requirements. With our continued growth in Canada, we are looking for proactive, positive, and self-motivated individuals with a shared commitment to quality to join our supportive and dynamic team.

• Act as the point of contact with sites during the study start up process;
• Prepare, review, and file clinical trial applications to Health Canada;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise clients on changing regulations and compliance requirements;
• Track and ensure timely filing of all documents related to Health Canada submissions.

• Proficiency in English and French;
• Ability to work in a remote setting;
• Bachelor’s degree in a science or health-related field;
• Experience working at a CRO is preferred;
• At least 3-5+ years of clinical research industry experience with HealthCanada and Ethics submissions;
• Knowledge of ICH guidelines and applicable local regulations; and
• Excellent written and oral skills.

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.

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 Best Mid-size Companies in 2021, 2022 and 2023
• 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.

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