Job Summary
A biotech research and development company is seeking a Remote Medical Writing Director.
Individual must be able to fulfill the following responsibilities:
- Manage or oversee multiple writing projects to support company, department, and project team goals with respect to project scope, messaging, timelines, other activity planning, and budgeting/resourcing
- Provide regulatory writing strategy for product development with the vision to identify immediate and future needs
- Ensure efficient preparation and completion of high-quality, accurate, concise, and ICH-compliant medical writing deliverables
Skills and Requirements Include:
- Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules
- Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs
- Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents)
