Non-clinical Medical Writer (contract)

CRISPR Therapeutics

Boston, Massachusetts, US
Base: $150 to $170 ph; bonus/equity: not specified...
Author nonclinical regulatory documents
Nonclinical study reports review
Ich and fda guidelines
The Nonclinical Medical Writer is responsible for the development of nonclinical documents for submission to the relevant health authorities

Job Summary

  • The Nonclinical Medical Writer is responsible for the development of nonclinical documents for submission to the relevant health authorities.
  • Author the nonclinical parts of regulatory documents in collaboration with nonclinical SMEs and ensure compliance with applicable regulations.
  • CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals.

Matching Summary

The Nonclinical Medical Writer is responsible for the development of nonclinical documents for submission to the relevant health authorities.

Salary

Base: $150 to $170 per hour; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Author nonclinical regulatory documents
  • Nonclinical study reports review
  • ICH and FDA guidelines
  • MS Office proficiency
  • Cell and gene therapy experience

Nice-to-have

  • Collaborative and good communication
  • Flexible attitude
  • Veeva Vault or similar experience
  • Novel platform technologies

Key Requirements

  • Bachelor's degree with 8-10 years experience
  • Master's/PhD with 3-5 years experience
  • Direct authoring experience for IBs, CTAs, INDs
  • Experience with multiple regulatory health authorities
  • Proficiency in MS Word

Work Rights

Not specified

Tailored Resume

Cover Letter