Medical writer

• Support one or more therapeutic areas within the Regulatory Medical Writing team
• Author diverse regulatory medical writing documents
• Write and coordinate basic clinical documents, including Phase 1 protocols, Phase 1/2 CSRs, tables of studies, narratives, and initial IBs
• Write, contribute to, and coordinate low- to medium-complexity clinical and regulatory documents, including Phase 2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses
• Perform document quality control, compile abbreviations and references, conduct literature searches, and complete other basic tasks
• Participate in and potentially lead cross-functional document planning and review meetings
• Take an active role in project timing, scheduling, and tracking
• Interact with cross-functional colleagues on document content and champion medical writing processes and best practices
• Establish document timelines and strategies in accordance with internal processes
• Guide or train cross-functional team members on processes and best practices as experience increases
• Lead early- or late-stage compound writing teams with supervision as required
• Learn and adhere to SOPs, templates, best practices, policies, and the Medical Writing Style Guide
• Attend departmental and cross-functional meetings
• Complete time reporting, training, metrics database, and project tracking updates
• Maintain and apply knowledge of industry, company, and regulatory guidelines
• Mentor junior staff on document planning, processes, content, or peer review
• Interact with or oversee contractors and external service providers under close supervision

Medical writer jobs in Belgium

Medical Writer II