Senior/Principal Medical Writer

📋 Description Lead the preparation of complex clinical and regulatory documents (Protocols, CSRs, CTD summaries Collaborate with clinical teams and stakeholders to produce accurate, compliant documentation. Provide document-specific guidance and strategic writing support to clients and project teams. Manage timelines, reviews, and deliverables to meet regulatory standards. Coordinate contributions from medical writers, QA, and supporting team members. Monitor budgets and ensure timely delivery within procedures. 🎯 Requirements Several years of experience writing clinical regulatory documents in pharma/biotech/healthcare. Lead writer experience for multiple regulatory document types (3+ of: Protocols, CSRs, CTD Senior level: lead more than three regulatory writing projects; Principal: lead more than five Principal: experience with multiple CTD dossier types (new chemical entity, variations, generics Experience working with clients and cross-functional teams, managing reviews and timelines. Strong understanding of regulatory documentation standards and document management tools. 🎁 Benefits Fully remote work environment with flexibility within Europe. Opportunity to contribute to meaningful clinical development programs. Competitive compensation aligned with experience. Standard benefits package and professional development opportunities. Work with experienced medical writing professionals and international teams. High ownership and responsibility across impactful regulatory projects.