Senior Medical Writer
Core
Authoring and coordinating complex clinical regulatory documents for vaccines and medicines to support global R&D and regulatory submissions.
Role type
Senior Medical Writer (Clinical Regulatory)
Builds
Regulatory submission packages (NDA/MAA CTD), clinical study reports, protocols, and investigator brochures for global markets.
Domain
Biopharmaceuticals / Clinical Research / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design, statistical data interpretation, regulatory document drafting, ICH/GCP compliance, scientific writing, stakeholder coordination
Preferred skills
PhD or Master's degree, 8+ years pharmaceutical writing experience, drug development lifecycle knowledge
Technologies
Clinical Trial Management Systems, Regulatory Submission Platforms
Responsibilities
Draft and review regulatory documents (protocols, CSRs, IBs) independently or with mentorship; ensure data integrity and document consistency; coordinate with clinical leads and biostatisticians; manage multiple simultaneous assignments.
Seniority
Senior, hands-on IC
