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 an 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: 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;Maintain database and spreadsheets as necessary to facilitate tracking and documentation of departmental activities. Qualifications: A minimum of a Bachelor's 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;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.
Perks: (vary by location and position)
On-site fitness center(s)Campus walking pathsCompany-sponsored social and wellness eventsOfficial Sponsor of FC CincinnatiHybrid work-from-home options and flexible work scheduleOn-site Market PlaceFree and covered parkingDiscounts for local businessesOn campus restaurants and banks coming soon Awards: Medpace historically named a Top Cincinnati Workplace by the Cincinnati EnquirerRecognized by Forbes as one of America's Best Mid-size Companies in 2021Medpace 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 availabilityContinually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibilityRanked 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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