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Project Assistant (Regulatory Affairs)
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Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our team!
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Project Assistant 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.
DESCRIPTION OF JOB DUTIES
* Provide day-to-day departmental/project support activities, such as maintenance of project-related files and faxing documents to sites;
* Coordinate and provide minutes for department/project meetings or conference calls;
* Conduct quality control of documents;
* Assist the Regulatory Affairs Managers in required project duties including creating and maintaining meeting agendas, minutes and timelines for Sponsor projects, filing, working electronically to conduct information searches and work document pre-publication tasks, file FDA correspondence, and other projects as needs arise;
* Maintain spreadsheets and compile reports; 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.; and
* Perform other tasks as needed for the regulatory affairs and regulatory publishing teams.
* Bachelor's Degree in a Life Science Field;
* Basic knowledge of medical terminology and a working knowledge of drug development services;
* Excellent analytical, written and oral communication skills; and
* Excellent computer skills, especially a strong knowledge of Microsoft Excel.
At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.
WHAT TO EXPECT NEXT
We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.
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