Senior Medical Writer – Client Aligned (FSP)
Core
Develop high-quality clinical and regulatory documents for a client in the FSP space, ensuring alignment with regulatory guidelines and company standards.
Role type
Senior Medical Writer (Client Aligned)
Builds
Clinical study reports, protocols, investigator brochures, and regulatory submissions
Domain
Pharmaceutical/CRO industry, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory writing, project management, team mentorship, knowledge of drug development processes, quality control processes
Preferred skills
Structured Content Authoring systems, automation, EU CTR experience
Technologies
Structured Content Authoring systems
Responsibilities
Write and edit clinical and regulatory documents, collaborate with cross-functional teams to ensure document accuracy, manage timelines and deliverables, mentor junior medical writers, review documents prepared by other team members
Seniority
Senior, hands-on IC with leadership responsibilities
