Country Regulatory Submissions Specialist
1 semana atrás
As a Regulatory Submissions Coordinator at Medpace, Inc., you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining vital experience in study start up. You will be a productive member of the team, and will be mentored and supported as you develop your skills. Working directly with Regulatory Submissions Coordinators, you will gain valuable hands-on experience to enable you to develop a career in clinical research.
Responsibilities- Provide day-to-day departmental/project support activities, such as collection of vital documents for ethics submissions and preparation of study documents to competent authorities;
- Support Regulatory Submission Managers and Start Up teams in ensuring deadlines are adhered to;
- Conduct quality control of documents;
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements;
- Perform other tasks as needed.
- Bachelor's degree is required (preferably in a Life Sciences field) and at least 3 - 4 years of regulatory submissions experience;
- Excellent organizational and prioritization skills;
- Knowledge of Microsoft Office;
- Great attention to detail and excellent oral and written communication skills;
- Fluency in spoken and written English.
We kindly ask to submit applications in English.
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