Principal Medical Writer

Job Summary

To support clinical-stage programs, the full-time Principal Medical Writer will independently author and oversee the development of high-quality submission-ready documents while collaborating with cross-functional stakeholders in a remote environment.

Key Responsibilities

• Plan, author, and deliver submission-ready documents including protocols, INDs, and briefing documents
• Lead cross-departmental document development by collaborating with Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams
• Establish and refine medical writing processes and manage efficient document workflows and timelines

Required Qualifications

• Bachelor's degree in a life science or health-related field required; advanced degree preferred
• Minimum 10 years of relevant medical writing experience with demonstrated experience in IND submissions
• Strong understanding of FDA/EMA regulations and ICH guidelines
• Highly skilled in Microsoft Office suite, particularly MS Word, with experience in electronic document management systems preferred
• Ability to thrive in a fast-paced environment and collaborate effectively across teams