Regulatory Affairs Document Specialist - Entry Level
Looking for an opportunity to begin a career in Regulatory Affairs Operations and clinical drug development?
Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Document Specialist to join our Regulatory Affairs Operations team. This is an excellent way to gain experience in the Regulatory Operations career field with exciting opportunities to advance and develop a career at Medpace.
Responsibilities
- Apply appropriate document properties, hyperlinks, and bookmarks to Clinical Study Reports, IND documents, NDA documents, and other regulatory documents according to ICH, eCTD, and other applicable electronic publishing standards;
- Use software to create submissions to regulatory authorities in compliance with appropriate regulatory standards;
- Navigate and review electronic submissions;
- 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;
- Develop understanding and maintain knowledge of appropriate standard operating procedures (SOPs), regulations, policies, and regulatory guidance documents; and
- May be responsible for other projects and responsibilities as assigned
Qualifications
- Bachelor’s Degree life science related field required;
- Experience or willing to learn publishing tools: Adobe, Global Submit, etc;
- A rapid increase in eCTD document structure, system, & content knowledge is expected;
- Demonstrates a high attention to detail and the ability to successfully train & learn under the more advanced Specialists on how to conduct all quality assurance reviews in the specified areas required for document finalization; and
- Employee will be expected to increase communication skills and the ability to work with a diverse group of people.