Regulatory Submissions Coordinator
Job Summary
Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Graduate to join our Clinical Operations team as a Entry Level Regulatory Submissions Coordinator. This position plays a key role in the clinical trial management process at Medpace. 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
Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees;
Ensure submissions comply with applicable regulations and guidance documents;
Advise sponsors on changing regulations and compliance requirements;
Track submissions and ensure timely filing of documents;
Collection of essential documents and preparation essential documents packages for drug release; and
Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities.
Qualifications
A minimum of a Bachelors degree in Life Sciences is required;
At least one year of work experience as a Regulatory Submissions Coordinator;
Excellent organizational and prioritization skills;
Knowledge of Microsoft Office;
Hands-on experience preparing, reviewing, and submitting regulatory documentation; and
Fluency in English.
Travel: None
Note: Only CVs in English will be considered
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?
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarters campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
Perks (vary by location and position):
On-site fitness center(s)
Campus walking paths
Company-sponsored social and wellness events
Official Sponsor of FC Cincinnati
Hybrid work-from-home options and flexible work schedule
On-site Market Place
Free and covered parking
Discounts for local businesses
On campus restaurants and banks coming soon
Awards:
Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Recognized by Forbes as one of Americas Best Mid-size Companies in 2021
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati
What to Expect Next:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
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Medpace
Fecha de publicación: 04/03/2023
