Principal Medical Writer

ICON plc

Not specified; competitive within each country; va...
Fully remote
Bachelor's degree in science or health profession
3+ years experience with electronic documents and submissions
Lead writer for key regulatory submission documents
The role involves leading the development of high-quality regulatory and clinical documents to effectively communicate scientific information

Job Summary

  • The role involves leading the development of high-quality regulatory and clinical documents to effectively communicate scientific information.
  • Candidates will act as a key Medical Point of contact for clinical regulatory strategy and ensure compliance with industry standards.
  • ICON offers a competitive salary, diverse benefits including health insurance and retirement planning, and a commitment to an inclusive culture.

Matching Summary

The role involves leading the development of high-quality regulatory and clinical documents to effectively communicate scientific information.

Salary

Not specified; Competitive within each country; Various annual leave entitlements

Skills & Requirements

Must-have

  • Bachelor's degree in science or health profession
  • 3+ years experience with electronic documents and submissions
  • Lead writer for key regulatory submission documents
  • Clear understanding of clinical development phases and processes
  • Knowledge of international regulations and ICH guidelines

Nice-to-have

  • 5+ years experience writing for pharma or biotechnology
  • Experience managing writing activities for major submissions
  • Ability to provide functional and cross-functional guidance
  • Strong problem-solving and interpersonal skills

Key Requirements

  • Bachelor's degree in science or health profession required
  • At least 3 years of electronic documents and submissions experience
  • Experience as lead writer for Clinical study reports, IBs, Protocols

Work Rights

Not specified

Tailored Resume

Cover Letter