Senior Medical Writer/Principal Medical Writer

Key Responsibilities:

• Plan, write, edit, format, and QC review clinical documents such as protocols, IBs, ICF templates, DSURs, CSRs, and patient narratives.
• Collaborate with sponsors, vendors, and internal teams for effective document management from start to finish.
• Independently formulate key messages from clinical data and author complex content.

Qualifications:

• Minimum BS degree in a scientific or medical discipline with 5+ years (Sr.) or 7+ years (Principal) of medical writing experience in sponsor/CRO.
• Proficiency in Microsoft Windows, Teams, Word, Excel, Adobe Acrobat, and PowerPoint.
• Clear understanding of ICH, FDA, GCP, and eCTD requirements for all development phases.

Preferred Skills:

• Advanced degree (MS/PhD) with oncology and/or rare disease experience.
• Impeccable attention to detail and ability to work in a fast-paced environment with multiple high-priority projects.