Senior/Principal Medical Writer

📋 Description Lead preparation of regulatory documents (Protocols, CRs, CTD summaries, IBs, IMPDs/INDs Collaborate with clinical teams to ensure accuracy and regulatory compliance. Provide document-specific guidance to clients and project teams. Manage timelines, reviews, and deliverables; ensure quality and regulatory standards. Coordinate contributions from medical writers and QA staff. Monitor budgets and ensure on-time delivery within procedures. 🎯 Requirements Several years writing clinical regulatory documents in pharma/biotech/healthcare. Lead writer for multiple regulatory document types (≥3 types). Senior: lead >3 projects; Principal: lead >5 projects. Principal with multiple CTD dossier types is desirable. Experience with client interaction, authors, cross-functional teams. Strong regulatory writing skills and document management familiarity. 🎁 Benefits Fully remote work environment with Europe-wide flexibility. Opportunity to contribute to meaningful regulatory programs. Competitive compensation aligned with experience. Standard benefits package and professional development. Collaborate with experienced medical writers and international teams. High ownership and responsibility across regulatory projects.