Principal/Sr Principal Medical Writer (Regulatory Submission)
- Writing types
- Regulatory
- Seniority
- Lead or manager
About the role
Responsibilities
- Develop regulatory documents for submission to agencies globally per ICH and other guidelines
- Manage medical writing projects, timelines and cross-functional communication
- Participate in cross-functional meetings on deliverables, timelines and processes
- Review protocols and statistical analysis plans for assigned projects
- Participate in process improvement initiatives and define SOPs and best practices
- Manage internal and contract medical writing resources
- Mentor more junior medical writing staff
About the Company
Syneos Health is a fully integrated biopharmaceutical solutions organization accelerating customer success across clinical development, medical affairs and commercial work.
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