Principal / Sr Principal Medical Writer (Regulatory Submission )
RemoteFull-timeLead levelPosted 2 weeks ago
Leadership pharma role at Syneos Health. Remote.
About the role
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
What you'll do
- 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 (working with the study/project teams
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate
- Participate in cross-functional process improvement initiatives
What you need
- SOP writing
- Customer success
- Communication