- Write, edit, prepare and publish clinical and regulatory documents, including integrated clinical statistical reports, protocol synopses, protocol amendments, informed consent, annual reports and investigator brochures
- Participate in ongoing programs and projects for clinical work teams to drive the pipeline of products within regulatory processes
- Prepare documents in accordance with SOPs
- Coordinate and prioritize multiple projects to align with project timelines
- Actively promote safety rules and awareness
- Experience independently authoring CSRs, protocols and regulatory submission documents, IND and NDA components
- Experience within pharmaceutical scientific documents and drug development cycles
