Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
Deep familiarity with ICH-GCP standards, FDA/EMA regulatory expectations, and the scientific rigor required in investigator brochures and medical affairs materials
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
5+ years in cybersecurity GRC, IT audit, or information security compliance, with direct ownership of SOC 2, ISO 27001, or NIST framework certification work
Hands-on experience writing or reviewing risk assessments, control matrices, and vendor security questionnaires against a named regulatory or audit framework
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
5+ years in cybersecurity GRC, IT audit, or information security compliance, with direct ownership of SOC 2, ISO 27001, or NIST framework certification work
Hands-on experience writing or reviewing risk assessments, control matrices, and vendor security questionnaires against a named regulatory or audit framework
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
5+ years in corporate accounting, financial operations, or internal/external audit support, with hands-on ownership of close reconciliations and audit request schedules
Deep fluency in GAAP, PBC documentation standards, and spreadsheet-based control testing (Excel/Google Sheets, pivot tables, VLOOKUP/XLOOKUP, macros)
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail