Medical Writer II
Core
Lead the development of high-quality regulatory and clinical documents to support clients' submissions to regulatory authorities.
Role type
Senior IC medical writer (regulatory/clinical)
Builds
Regulatory submissions, Clinical study reports, Investigator's Brochures, Protocols
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical writing, Clinical development lifecycle, International regulations (ICH), CTDs, Protocol design, Clinical study reports, Investigator's Brochures
Preferred skills
Pharma/biotech writing experience, Electronic submissions, Cross-functional leadership
Technologies
Electronic document systems
Responsibilities
Coordinate assignments and review documents, Formulate writing approaches and timelines, Provide advanced input for study designs and INDs, Manage deliverables for regulatory agencies, Represent medical writing on cross-functional teams, Serve as key medical point of contact for clinical regulatory strategy
Seniority
Senior, hands-on IC
