BioForum

Medical writer

• Draft regulatory documents, including clinical study protocols, reports, and investigator brochures, across various therapeutic areas with minimal supervision
• Prepare complex documents, such as clinical summary CTD documents, under guidance
• Support Bioforum’s medical writing projects by reviewing and editing internal documents
• Ensure compliance with internal training, guidelines, templates, and SOPs for therapeutic area-specific documents
• Collaborate with a US-based pharmaceutical client to produce clinical documents, including study protocols, reports, informed consent forms, and investigator brochures
• Participate in process improvement initiatives and working groups within the medical writing team and global development
• Oversee junior and outsourced medical writers by reviewing their work and mentoring as needed
• Review CSR-related materials, such as statistical analysis plans and TFLs, to confirm appropriate inclusion
• Create plain language documents where required, explaining complex medical or scientific concepts for lay or patient audiences
• Facilitate and lead cross-functional document review meetings, clarify client feedback, and integrate comments effectively
• Review and edit documents and deliverables to ensure quality and accuracy
• Represent the client’s medical writing department in meetings and discussions
• Develop and articulate document strategies and timelines
• Resolve content-related discussions efficiently and succinctly synthesize outcomes into clear, accurate text

Senior Medical Writer