Description
Regulatory Technical Writer/EditorKey Responsibilities: reviewing, formatting, and editing regulatory documents, including NDAs, MAAs and INDs in the common technical document format, briefing documents, annual reports, CSRs, IBS, and IMPDs.
Duties/Responsibilities
- Critically assess, interpret, and summarize nonclinical, clinical, and manufacturing data to improve readability and presentation of regulatory documentation to produce high-quality submissions to regulatory agencies.
- Coordinate with Regulatory team members to manage timelines for regulatory submissions
- Organize and manage tasks related to the development of regulatory documents to ensure that timelines are met and that documents are completed according to the companies standards and processes
- Ensure consistency within documents and across clinical programs by managing messaging and maintaining document standards.
Requirements
- Detailed knowledge of AMA manual of style, complex grammar, and general medical terminology
- Experience with electronic submissions and document templates
- A solid understanding of clinical data analysis
- Excellent teamwork, organization, and project management skills, ability to interact directly and effectively with team members and clinical experts
- Outstanding written communication skills and attention to detail, exceptional follow-through with assigned tasks, self-motivated
- Ability to integrate/interpret and summarize scientific data from a variety of primary sources in a clear and concise manner
- Ability to produce documents that are well organized, accurate, consistent, and in compliance with the companies style and GxP regulations
Education
- B.A. in life science or English; at least 5 years experience in technical writing for pharmaceutical industry required
To find out more about Real please visit www.realstaffing.com