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Regulatory Submissions Manager Nr ref.: /JOBS.pl 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 45 countries across the globe. Medpace has recently expanded into Turkey and we are currently seeking a full-time, experienced Manager to lead the Start up activities in the country. This position will be an integral member of the local and global clinical operations teams. 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 •Primary contact for global and local team to manage and execute start up activities. This includes: •Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications; •Develop procedures for local start up processes; •Prepare and submit clinical trial applications to regulatory agencies; •Manage incoming questions from local regulatory and ethics agencies; •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; and •Present during bid defenses, general capabilities meetings, and audits. QUALIFICATIONS/REQUIREMENTS •5 years of experience in clinical research with experience and knowledge of start up requirements in Turkey (either as CRA or regulatory expert) •Knowledge and experience with Clinical Trial Applications •At least bachelor's degree in life sciences; •Excellent organization and communication skills; •Knowledge of Microsoft® Office; •Fluency in English and Turkish. WHY MEDPACE? Finding work that is challenging, where you are given the tools and training to succeed, where you are rewarded and are provided opportunities to grow professionally are just a few reasons talented individuals join the Medpace team. 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. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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