- MUST have oncology experience
- write, edit, prepare, and publish clinical and regulatory documents, including integrated clinical statistical reports, protocol synopses, protocols 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, which may include but are not limited to clinical study protocols and amendments, IBs, CSRs, DSURs, and other documents as needed
- Coordinate and prioritize multiple projects to align with project time lines
- 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
