Medical Writer

• Compile, write, edit, and coordinate medical writing deliverables presenting scientific information clearly and accurately
• Complete clinical study protocols and protocol amendments, clinical study reports, patient narratives, and investigator brochures
• Apply regulatory standards, ICH E3 guidelines, SOPs, client standards, approved templates, authorship requirements, and style guides
• Coordinate quality and editorial reviews, lead document reviews, and resolve client comments
• Manage source documentation appropriately
• Review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency
• Build working relationships with clients, department heads, and peers
• Perform online clinical literature searches while complying with copyright requirements
• Identify and propose solutions to document issues, escalating when appropriate
• Continue professional development and improve awareness of industry standards and best practices
• Work within assigned project budgets and communicate status or changes to medical writing leadership
• Complete required administrative tasks and other assigned duties

• Work as a medical writer with moderate supervision
• Ability to compile, write, edit, and coordinate medical writing deliverables
• Ability to complete clinical study protocols and protocol amendments, clinical study reports, patient narratives, and investigator brochures
• Knowledge of ICH E3 guidelines and regulatory standards
• Ability to follow company and client standard operating procedures, templates, authorship requirements, and style and formatting guides
• Ability to coordinate quality and editorial reviews and manage source documentation
• Ability to review statistical analysis plans and table/figure/listing specifications
• Ability to perform online clinical literature searches and comply with copyright requirements
• Ability to identify and propose solutions to document issues
• Ability to work within budgeted hours and communicate status and changes to medical writing leadership
• Minimal travel may be required (less than 25%)
• Equivalent experience, skills, and/or education may be considered

Demonstrates expertise in medical writing, including the ability to compile, write, edit, and coordinate clinical study documents while adhering to regulatory standards and ICH E3 guidelines. Proficient in managing quality reviews and maintaining effective communication with clients and stakeholders.

• Medical Writing
• Clinical Study Protocols
• ICH E3 Guidelines
• Quality Review Coordination
• Statistical Analysis Review

• Medical Writing Deliverables
• Clinical Study Reports
• Protocol Amendments
• Patient Narratives
• Investigator Brochures
• Regulatory Standards
• SOPs
• Document Issue Resolution
• Online Clinical Literature Searches
• Budget Management

• Communication
• Collaboration
• Problem Solving
• Relationship Building
• Attention to Detail

• Regulatory Standards
• ICH E3 Guidelines
• Copyright Compliance
• Editorial Reviews
• Document Management