Description
Syneos Health is seeking a Principal/Sr Principal Medical Writer (Regulatory Submission) to develop regulatory documents for submission to regulatory agencies globally.
The successful candidate 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 to ensure timely completion of assigned projects
- Mentor more junior medical writing staff
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and a total rewards program.
The company is committed to its Total Self culture, which encourages authenticity and inclusivity.