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

• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field
• Bachelor’s degree or higher in a relevant field
• Experience writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
• Flexibility to work across multiple therapeutic areas
• Experience writing documents according to established processes and document templates
• Familiarity with lean authoring approaches and structured content management
• Familiarity with ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements desired
• Expertise with Microsoft Word and other Microsoft applications
• Experience with document management systems, collaborative authoring tools, and review tools
• Ability to adapt to new tools and technologies
• Ability to work independently and collaboratively amid competing priorities
• Service-oriented and proactive approach to project management
• Conflict management and negotiation skills
• Strong written and verbal communication skills
• Oncology, Infectious Disease, or Vaccine experience desired

• Equal employment opportunity regardless of race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by law