Regulatory Submissions

Job SummaryOur clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Clinical Operations team in Milan, Italy. 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.ResponsibilitiesEfficiently manage and successfully execute all aspects of global start-up;Perform quality checks on submission documents and site essential documents;Prepare and approve informed consent forms;Review pertinent regulations to develop proactive solutions to start-up issues and challenges; andPresent bid defenses, general capabilities meetings, and audits.QualificationsAt least 4 years of experience in clinical research, preferably with a CRO. Experience may include CRA or project management experience;Knowledge and experience of Clinical Trial Applications within Europe;Strong oral and written communication skills;Team oriented approach and strong leadership skills; andFluency in English.Medpace OverviewMedpace 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 andtherapeutic 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 4, people across almost 40 countries.Why MedpaceWhen 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.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 LinkedIn Top Companies list in CincinnatiWhat to Expect:
A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.EO/AA Employer M/F/Disability/VetsJob SummaryCategory:
Clinical Operations