Senior Medical Writer

Precision Medicine Group

Remote, US
Base: $101,800 - $152,600; bonus/equity: discretio...
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5+ years medical writer experience
Regulatory guidelines ich fda gcp
Ectd requirements knowledge
** Precision Medicine Group is seeking a Senior Medical Writer who will be responsible for creating high-quality clinical study documents in a remote setting. The ideal candidate should possess at least 5 years of medical writing experience, particularly in a sponsor or CRO environment, and have a solid understanding of regulatory requirements. **

Job Summary

  • The Senior Medical Writer will lead the development of high-quality clinical study documents including protocols, CSRs, and patient narratives.
  • Candidates must ensure all documents comply with Precision MW Style Guide, SOPs, and applicable regulatory guidelines like ICH, FDA, and GCP.
  • This role offers a competitive salary range of $101,800 to $152,600 along with discretionary annual bonuses and comprehensive benefits.

Matching Summary

Match Score: 75

** Precision Medicine Group is seeking a Senior Medical Writer who will be responsible for creating high-quality clinical study documents in a remote setting. The ideal candidate should possess at least 5 years of medical writing experience, particularly in a sponsor or CRO environment, and have a solid understanding of regulatory requirements. **

Salary

Base: $101,800 - $152,600; Bonus/Equity: Discretionary annual bonus available; Benefits: Health insurance, retirement savings, life insurance, disability, parental leave, PTO

Skills & Requirements

Must-have

  • 5+ years medical writer experience
  • Regulatory guidelines ICH FDA GCP
  • eCTD requirements knowledge
  • Clinical study protocol writing
  • CSR and IB document development

Nice-to-have

  • Advanced degree MS or PhD
  • Oncology or rare disease experience
  • Strong problem-solving skills
  • Independent work in fast-paced environment

Key Requirements

  • BS degree in scientific or medical discipline
  • 5+ years experience as medical writer
  • Proficiency with Microsoft Office and Adobe Acrobat

Work Rights

Not specified

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