Medical Writing Manager (Hybrid)
Core
Lead Medical Writing Scientist preparing moderately complex clinical and regulatory documents for clinical studies.
Role type
Senior IC medical writing manager
Builds
Clinical study protocols, clinical study reports, investigator's brochures, regulatory submissions, and product development plans
Domain
Biotechnology / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical regulatory document authoring, data analysis and interpretation, cross-functional stakeholder collaboration, project management, scientific consistency management, standard operating process development
Preferred skills
Drug development lifecycle knowledge, biostatistics, pharmacology, medical terminology expertise
Technologies
Word processing, document management systems, electronic review systems, literature search tools
Responsibilities
Author moderately complex clinical regulatory documents; Serve as lead Medical Writing Scientist for clinical studies; Support review and interpretation of clinical study data; Develop key messages for regulatory documents; Ensure medical and scientific consistency across clinical programs; Contribute to product development plans; Participate in developing standard operating processes
Seniority
Senior, hands-on IC
