Principal Medical Writer
Core
Lead the design, planning, authoring, editing, and review of accurate, clear, and compliant clinical, regulatory, and public-facing documents across multiple programs and therapeutic areas.
Role type
Principal Medical Writer (Strategic & Leadership)
Builds
Regulated content for clinical development pipelines and public-facing materials
Domain
Pharmaceutical / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical Writing, Regulatory Compliance, Clinical Studies, Project Management, Strategic Thinking, Data Analysis, Good Clinical Practice (GCP), Health Literacy, Standard Operating Procedure (SOP), Stakeholder Alignment
Preferred skills
Clinical Trials, Leadership, Regulatory Submissions, Technical Knowledge
Responsibilities
Lead the review of clinical and regulatory documents; Provide program oversight and escalate issues impacting timelines or compliance; Mentor and coach other medical writers; Lead initiatives to improve medical writing processes and standards; Manage direct reports including workload and performance.
Seniority
Principal, hands-on IC with leadership responsibilities
