Medical Writer (FSP) - Client Aligned
Core
Develop high-quality clinical and regulatory documents for clients in the FSP space, ensuring alignment with regulatory guidelines and company standards.
Role type
Senior Medical Writer (Regulatory/Clinical)
Builds
Clinical study reports, protocols, investigator brochures, and regulatory submissions
Domain
Pharmaceutical/CRO industry, Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory writing, Clinical study report authoring, Protocol development, Investigator brochure creation, Regulatory submission preparation, Cross-functional collaboration, Project timeline management, Industry guideline knowledge
Preferred skills
Structured Content Authoring systems, Automation tools, EU CTR experience
Technologies
Structured Content Authoring systems, Automation tools
Responsibilities
Write and edit clinical and regulatory documents, Collaborate with cross-functional teams to gather information, Ensure documents align with regulatory guidelines, Manage timelines and deliverables, Stay current with industry trends and guidelines
Seniority
Mid-Senior, hands-on IC
