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
Required skills
Clinical regulatory document authoring, data analysis and interpretation, cross-functional stakeholder management, project management, scientific consistency review, standard operating process development
Preferred skills
None stated
Technologies
Word processing, templates, table/figure creation, literature search tools, electronic review systems, document management systems
Responsibilities
Author moderately complex clinical regulatory documents; Serve as lead Medical Writing Scientist for moderately complex clinical studies; Support review and interpretation of clinical study data; Develop key messages for regulatory documents; Ensure medical and scientific consistency across documents; Analyze and interpret data to determine document composition approach; Contribute to product development plans; Participate in developing standard operating processes
Seniority
Senior, hands-on IC
