Lead Safety & Regulatory Medical Writer

IQVIA Inc

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Authoring dsurs and psurs/pbrers
Knowledge of ich ema fda regulations
Integrating clinical and statistical data
** IQVIA Inc is seeking a Lead Safety & Regulatory Medical Writer to lead the authoring and delivery of safety and regulatory documents, particularly aggregate safety reports. The ideal candidate will have over five years of medical writing experience, with a strong emphasis on safety writing and a deep understanding of global regulatory requirements. **

Job Summary

  • The role involves leading the authoring of critical safety and regulatory documents such as DSURs and PBRERs for global clients.
  • Candidates must ensure all deliverables comply with strict international regulations including ICH, EMA, and FDA guidelines.
  • This position requires mentoring junior writers while managing multiple projects to meet client timelines and quality standards.

Matching Summary

Match Score: 75

** IQVIA Inc is seeking a Lead Safety & Regulatory Medical Writer to lead the authoring and delivery of safety and regulatory documents, particularly aggregate safety reports. The ideal candidate will have over five years of medical writing experience, with a strong emphasis on safety writing and a deep understanding of global regulatory requirements. **

Skills & Requirements

Must-have

  • Authoring DSURs and PSURs/PBRERs
  • Knowledge of ICH EMA FDA regulations
  • Integrating clinical and statistical data
  • Managing document timelines and reviews

Nice-to-have

  • Mentoring junior medical writers
  • Cross-functional team collaboration
  • Project planning and budget tracking

Key Requirements

  • Bachelor's degree in Life Sciences (Master's or PhD preferred)
  • 5+ years of Medical Writing experience
  • Significant Safety Medical Writing responsibility
  • Hands-on experience with aggregate safety reports

Work Rights

Not specified

Tailored Resume

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