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, including project management tasks and timeline communication
• Coordinate cross-functional client contributors, stakeholders, and internal resources such as quality control and publishing
• Ensure document development follows client processes, templates, and instructions
• 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 and 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
• Perform peer quality-control reviews
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management
• Partner cross-functionally with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management teams

Senior Medical Writer

• Partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program 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 and project management tasks, including creating, maintaining, and communicating timelines
• Coordinate 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
• Plan and lead kickoff meetings
• Facilitate review feedback 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 QC 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, 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 reviews as needed
• Contribute to medical writing operational initiatives such as templates, style guides, and reference management

• Lead development of high-quality, on-time clinical study documents
• Plan, write, edit, format, and perform QC review of clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
• Develop documents in compliance with Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements
• Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision teams/departments
• Independently formulate key messages from clinical study data
• Author complex content using knowledge, skills, and process understanding
• Communicate clearly and concisely with internal and client teams
• Contribute to medical writing processes, SOPs, templates, and work instructions
• Perform literature-based research to support writing activities
• Perform other duties as assigned

Senior Medical Writer/Principal Medical Writer

• Lead the development of high-quality, on-time clinical study documents
• Plan, write, edit, format, and perform QC review of clinical study protocols, IBs, ICF templates, DSURs, CSRs, and CSR patient narratives
• Develop documents in compliance with Precision MW Style Guide, Precision SOPs, ICH, FDA, GCP, and eCTD requirements
• Manage documents from template through final approved version in collaboration with sponsors, external vendors, and internal Precision project teams/departments
• Independently formulate key messages from clinical study data
• Author complex content using relevant knowledge, skills, and process understanding
• Communicate clearly and concisely with internal and client teams, in writing and verbally
• Contribute to developing and maintaining medical writing processes, SOPs, templates, and work instructions
• Perform literature-based research to support writing activities
• Perform other duties as assigned

• Independently plan and prepare regulatory documents and medical communications supporting all phases of product development
• Organize, analyze, interpret, and present scientific and statistical information
• Ensure documents comply with ICH, other regulatory guidelines, and company document standards
• Work under the direction of Medical Writing management
• Collaborate with cross-functional internal and external document production teams