Job Summary
A pharmaceutical company needs applicants for an opening for a Remote Senior Medical Writer.
Must be able to:
- Collaborate with the study team, draft, edit, and finalize CSRs for Phase 1-3 clinical studies
- Represent Medical Writing in regularly scheduled clinical project team meetings
- Plan and lead document review meetings to achieve consensus on document strategy, content, and format
Skills and Requirements Include:
- Minimum of Bachelor’s degree, preferably in a health-related or scientific discipline
- 5 years medical writing experience in a pharmaceutical, biotechnology, or CRO environment
- Experience writing Phase 1-3 clinical protocols and CSRs required
- Exceptional written and verbal communication skills
- Thorough knowledge of clinical research concepts and practices, FDA regulations, and ICH Guidelines
- Ability to manage large projects with minimal supervision
