Description
We are seeking a Principal Medical Writer to develop regulatory documents for submission to regulatory agencies globally. As a Principal Medical Writer, you will manage medical writing projects, participate in cross-functional meetings, and mentor junior medical writing staff.
Responsibilities:
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes
- Manage medical writing projects, including developing timelines and communication with cross-functional team members
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes
- Review other documents associated with assigned projects, such as Protocols and Statistical Analysis Plans
- Participate in cross-functional process improvement initiatives
- Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents
- Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
- Mentor more junior medical writing staff
About Syneos Health: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.