Medical Writing Manager (Hybrid)
Core
Preparing moderately complex clinical and regulatory documents and serving as a lead scientist for clinical studies.
Role type
Medical Writing Science Manager
Builds
Clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions
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, drug development knowledge, clinical research study design, biostatistics, pharmacology, medical terminology, project management, cross-functional team leadership
Preferred skills
Standard operating process development, product development planning, document management system proficiency
Technologies
Word processing, templates, table/figure creation, literature search tools, electronic review systems, document management systems
Responsibilities
Authors moderately complex clinical regulatory documents, serves as lead Medical Writing Scientist for moderately complex clinical studies, supports review and interpretation of clinical study data, develops key messages for regulatory documents, ensures medical and scientific consistency across documents, analyzes and interprets data to determine document composition approach, contributes to product development plans, participates in developing standard operating processes
Seniority
Manager, hands-on IC with team leadership
