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Entry Level Publishing Associate, Regulatory Operations


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Company

medpace

Description

OverviewMedpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace's mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 3,000 people across 36 countries.Job SummaryOur corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Document Specialist to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company's success. 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* Publish Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards;* Implement publishing processes across multiple complex regulatory documents;* Perform document quality control checks for others in the department, promptly communicating irregularities in documents and coordinating issue resolution;* Assist Medical Writers in the development and compilation of appendices of Clinical Study Reports;* Provide day-to-day department support activities as necessary to aide completion of documents, including Clinical Study Reports, Report Appendices, Protocols, etc.;* Support management with the conduct of procedural and software training* Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents; and* May be responsible for other projects and responsibilities as assigned.Qualifications* Bachelor's Degree required;* A rapid increase in eCTD document structure, system, & content knowledge is expected.* Demonstrates a high attention to detail and the ability to successfully train & learn under the more advanced Specialists on how to conduct all quality assurance reviews in the specified areas required for document finalization; and* Employee will be expected to increase communication skills and the ability to work with a diverse group of people.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.Awards* Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer* Winner of the ACRP-Avoca CRO Quality Award in 2018* Recognized with six CRO Leadership Awards from Life Science Leader magazine* Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnershipsWhat to Expect NextWe look forward to receiving your application. 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/Vets* WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money. These scammers pose as legitimate employees from actual companies. Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.
Posted Date
10/09/2019

Listing ID
73177323
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