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Clinical Regulatory Submissions Specialist
1 week ago
Medpace, Inc. is a leading clinical contract research organization (CRO) dedicated to accelerating the global development of safe and effective medical therapeutics.
We are currently seeking a highly skilled Regulatory Submissions Coordinator to join our Clinical Operations team. This position will work closely with sponsors to prepare, review, and file clinical trial applications to domestic and international regulatory agencies.
The ideal candidate will have excellent organization and communication skills, as well as hands-on experience preparing, reviewing, and submitting regulatory documentation. A bachelor's degree in life sciences and at least 1 year of experience with IND submissions to MFDS are also required.
As a member of our team, you will be responsible for ensuring submissions comply with applicable regulations and guidance documents, advising sponsors on changing regulations and compliance requirements, and tracking submissions to ensure timely filing of documents.