Senior Medical Writer
Core
Leading the development of high-quality regulatory and clinical documents to support clients' submissions to regulatory authorities.
Role type
Senior IC medical writer (regulatory)
Builds
Regulatory submissions (INDs, marketing applications, Clinical study reports, IBs, 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, regulatory document preparation, study design input, analysis plan input, review and substantive editing, resource management, timeline formulation, international regulatory guidance knowledge, CTD knowledge
Preferred skills
Managing writing activities for major international regulatory submissions, experience in pharma or biotechnology
Technologies
Electronic documents and submissions systems
Responsibilities
Guide medical writing document preparation including coordination, review, and editing; Lead writing strategy; Provide advanced input for study designs and analysis plans; Manage deliverables for regulatory agency submissions; Represent Medical Writing on cross-functional teams; Act as key Medical Point of contact for clinical regulatory strategy; Serve as lead writer for important regulatory response documents.
Seniority
Senior, hands-on IC
