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 journalism, corporate communications, or public relations producing press releases, briefing memos, or editorial content under deadline pressure
Track record of shaping messaging for executives or media outlets, with sharp news judgment and command of AP style or equivalent editorial standards
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
Proven track record managing capacity planning models, inventory forecasting spreadsheets, or workflow process maps in a fast-paced operations environment
Experience authoring standard operating procedure playbooks and process improvement business cases that measurably reduced cost or cycle time
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail
5+ years running enterprise programs, PMOs, or cross-functional implementation initiatives with direct ownership of program charters, raid logs, and steering committee reporting
Fluency building resource capacity planning spreadsheets and milestone tracking spreadsheets that hold up under executive and stakeholder scrutiny
Expert-level document, spreadsheet, and slide craftsmanship, with excellent written communication and attention to detail