- Remote, Philippines
- Remote
- Full-time · Senior
- 5+ years
The Senior Medical Writer - Safety Focus is a major contributor to document authorship for a variety of aggregate safety reports within the safety service line, acting as project lead on smaller projects and supporting larger, more complex engagements.
Responsibilities
- Document authorship for a variety of aggregate safety reports
- Project lead on smaller projects, interfacing directly with the client
- Support larger, more complex engagements as a member of a larger delivery team
- Develop safety update reports (DSURs), Periodic safety update reports (PSURs), Periodic benefit-risk evaluations reports (PBRERs), Risk management plans (RMPs), Periodic adverse drug experience reports (PADERs), Addenda to clinical overviews (ACOs), and Safety topic reviews
- Lead internal project teams and anticipate the effects of writing practice conventions on health authority approval
Requirements
- Bachelor’s degree or higher in a scientific discipline