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SpecialismMedical Writing
Writers are judged by documents. We ask for the document types authored end to end, the review cycles managed and the therapeutic areas covered.
Roles we recruit
- Regulatory medical writer
- Clinical study report (CSR) and protocol writer
- CTD summaries (Module 2) writer
- Safety and aggregate-report writer
- Publications writer
- Medical writing lead
Skills and systems we screen for
- Protocols and CSRs (ICH E3)
- CTD Module 2 summaries
- Investigator brochures
- Publications (GPP, ICMJE)
- Data interpretation with statisticians
- Document review management
What we ask in the screening call
- Document types authored solo versus contributed
- Therapeutic areas
- Review-cycle ownership
- Writing sample available under NDA
Regulatory frameworks
Reference points we use when briefing and screening.
- ICH E3 / M4
- EMA
- FDA