Our clinical operations activities are growing rapidly, and we are currently seeking 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 study start-up process at Medpace. As a Regulatory Submissions Coordinator with Medpace Canada, you will gain exposure to diverse, challenging studies across all phases and multiple therapuetic areas. 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.
Responsibilities
- 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 study teams on changing regulations and compliance requirements;
- Track and ensure timely filing of all essential start-up documents including Health Canada submissions.
Qualifications
- Proficiency in English (required) and French (preferred)
- 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 Overview
Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.
Why Medpace?
When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.
Purpose-Driven Work
- Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence
Collaborative Culture
- Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
- Leadership throughout Medpace is both accessible and approachable
Continuous Growth & Development
- Office based environment with on-site mentors
- Defined career paths with clear advancement opportunities
- Industry renowned onboarding and training programs designed to accelerate professional development
- Ongoing training and continuous learning opportunities throughout your career
- An environment that encourages employees to influence change, contribute ideas, and grow quickly
Other Employee Benefits
- Competitive compensation programs that recognize and reward performance
- Comprehensive health, wellness, retirement, and PTO benefits
- Office based culture with occasional WFH that provides flexibility for eligible positions after training
- Company-sponsored social events and intramural sports
Cincinnati Headquarters Experience
- A modern corporate campus designed to support collaboration and productivity
- Multiple on-site dining options in the heart of Madison Square
- Free on-site parking
- Convenient access to on-site 24-7 fitness and wellness facilities
What to Expect Next
A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.
Originally posted on Himalayas