Medical Writer
Core
Authoring high-quality expert reports, statistical analysis plans, and clinical study documentation to support regulatory submissions and safety assessments for cardiac therapies.
Role type
Senior Medical Writer (Cardiac Safety)
Builds
Regulatory deliverables and clinical study documentation for pharmaceutical and biotechnology sponsors
Domain
Clinical research, Cardiac Safety, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical/scientific writing, Statistical Analysis Plan (SAP) development, Regulatory compliance (FDA/EMA/ICH), Clinical trial interpretation, Cross-functional collaboration, Project management, Microsoft Word proficiency
Preferred skills
Advanced degree (MSc/PhD/PharmD), Cardiology/ECG/electrophysiology trial experience, Process improvement
Technologies
Microsoft Office (Word)
Responsibilities
Author and finalize Expert Reports based on statistical outputs; Develop and maintain Statistical Analysis Plans (SAPs); Ensure scientific accuracy and regulatory alignment; Interpret study data for sponsors; Manage document timelines across multiple studies; Support protocol and synopsis development; Maintain knowledge of regulatory guidance.
Seniority
Senior, hands-on IC
