Medical writer

• Lead planning and preparation of high-quality clinical regulatory documents
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Lead document execution and project management, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure documents follow client processes, templates, and instructional documents
• Serve as an expert on client document management systems, tools, templates, and procedures
• Lead document message development with clients
• Interpret data and create shell documents
• Plan and lead kickoff meetings
• Facilitate review-feedback resolution and lead comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency across client programs in messaging, formatting, and document presentation
• Conduct literature searches as needed
• Perform peer quality-control reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

Senior Medical Writer

• Lead planning and preparation of high-quality clinical regulatory documents
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Lead document execution and project management tasks, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructional documents
• Serve as an expert on client document management systems, tools, templates, and procedures
• Lead document message development with clients
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review feedback resolution and lead comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency in messaging, formatting, and presentation across client programs
• Conduct literature searches as needed
• Perform peer quality-control review as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

• Lead planning and preparation of high-quality clinical regulatory documents
• Produce protocols, publications, study reports, investigator brochures, narratives, and module documents
• Lead document execution, including creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructional documents
• Serve as an expert on client document management systems and related tools
• Lead document message development with clients
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate review-feedback resolution and lead comment resolution meetings
• Follow up with team members to resolve outstanding review feedback
• Ensure consistency across client programs in document messaging, formatting, and presentation
• Conduct literature searches as needed
• Perform peer QC reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management