Senior Medical Writer

Overview

We’re seeking a senior medical writer to join a medical writing team and partner with client groups across Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management. The role focuses on planning and preparing high-quality clinical regulatory documents under tight timelines, with potential work on protocols, publications, study reports, investigator brochures, narratives, and module documents.

What You'll Do

• Lead the execution of medical writing projects and manage timelines throughout the document lifecycle.
• Coordinate client stakeholders and internal support teams, including QC and publishing, to keep documents on track.
• Ensure all deliverables follow client processes, templates, and supporting instructions.
• Use client document management systems and related tools efficiently to support document development.
• Lead message development with the client and help shape the overall document narrative.
• Interpret data and create shell documents to support authoring.
• Plan and run kickoff meetings and facilitate review cycles, including comment resolution meetings.
• Follow up with individual contributors to close outstanding review feedback.
• Maintain consistency across client programs in messaging, format, and presentation.
• Conduct literature searches when needed.
• Perform peer QC review when needed.
• Support operational initiatives such as templates, style guides, and reference management.

Requirements

• 5+ years of experience as a medical writer in the CRO, biotech, or pharmaceutical industry.
• 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 is preferred.
• Oncology, Infectious Disease, or Vaccine experience is desired.
• Ability to work across multiple therapeutic areas if needed.
• Experience working from established processes and document templates.
• Familiarity with lean authoring and structured content management.
• Understanding of ICH and U.S. regulatory requirements; working knowledge of ex-U.S. regulatory requirements is desired.
• Strong Microsoft Word and Microsoft Office skills.
• Experience with document management systems, collaborative authoring tools, and review tools.
• Ability to adapt to new tools and technologies.
• Comfort working independently and collaboratively under competing priorities.
• Service-oriented, proactive approach to project management.
• Strong conflict management, negotiation, written, and verbal communication skills in English.