- Briefing documents
- Protocols/amendments (Phase 1-4, registries)
- IBs
- CSRs
- IND
- NDA
- Narratives
- Annual reports
- Formatting Word documents
- PDF rendering
- Prepublishing (bookmarking, linking, etc.)
- Electronic submission through ESG
- Develop or provide input on study-related documents such as CRFs, laboratory manuals, ICFs
- Generate clinical content for publications, data review/safety meetings, decision-making taskforces, and Agency/IRB communications
- Provide medical monitoring support, including review of protocol deviations, line listings, and medical coding, generation of queries, and hosting of regular medical monitoring meetings
- Develop solutions (e.g., team site, trackers) to enhance medical monitoring efficiency and oversight of both patients and CRO activities
- Serve as site and CRO point of contact for protocol-related questions
- Develop clinical content for SIVs
- Publications – manuscripts, abstracts, posters, white papers, publication plans
- Literature searches/reviews
- Narrative automation
- Training
- SOP/style guide writing
- Redaction
- Project management / content plan development