Regulatory Submissions Coordinator, Study Start Up & Maintenance
Medpace Holdings, Inc.
Poland, Warsaw | Poland, Warsaw
Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based, with the option to work from home partially, Regulatory Submissions Coordinator to join our Clinical Operations 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.
Ours is a culture of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners. At Medpace our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons talented individuals join the Medpace team.
Entry Level positions are available for this role
- Prepare, review, and file clinical trial applications to country agencies and ethic committees;
- Provide insightful input on regulatory submissions documents and timelines;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise on changing country regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
- Excellent organization and communication skills, strong attention to detail;
- Fluency in English and Polish language;
- Knowledge of Microsoft® Office.