Medical writer
Core
Writing and quality-checking regulatory documents, primarily clinical study protocols and reports, for pharmaceutical and medtech industry clients.
Role type
Senior Medical Writer (Clinical Research)
Builds
Regulatory documents (protocols, reports, summaries) for clinical trials
Domain
Life Sciences / Clinical Research / CRO
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, drug development, clinical trials, regulatory guidelines (ICH E6, E3, ISO 14155), meeting coordination, medical coding, safety reporting, English (fluent), Swedish (fluent)
Preferred skills
Phase 2-3 trials, medical devices, advanced therapy medicinal products (ATMP), eCTD module 2, Investigator's Brochures, Annual Safety Reports
Technologies
Microsoft Office suite (Word)
Responsibilities
Write clinical study protocols and reports; coordinate development and quality control processes; lead internal and external meetings; mentor colleagues; write regulatory texts, abstracts, and safety reports
Seniority
Senior, hands-on IC
