Expert Regulatory Medical Writer Wanted

5 days ago


Sydney, New South Wales, Australia beBeeMedical Full time $90,000 - $145,000
Job Title:

Regulatory Medical Writer

About the Role:

We are seeking an experienced medical writer to coordinate, write and edit clinical study documents. The successful candidate will work remotely from anywhere in Australia.

Key Responsibilities:
  • Coordinate, write and edit Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs) and other clinical study documents.
  • Act as primary technical contact for other departments and clients for clinical study documents assigned.
  • Mentor medical writers on tasks and maintain quality processes.
Requirements:
  • Ordinary degree in a scientific or relevant discipline.
  • Higher degree in a scientific or relevant discipline (desirable).
  • Minimum 2 years of experience as a medical writer with prior experience in preparation of IBs, CSPs, PICFs, CSRs or other clinical trial documents.
  • Minimum 3 years of experience in the biotechnology/pharmaceutical/clinical research industry.
  • Strong research report writing skills and/or demonstrated experience in writing peer-reviewed journal articles.
  • Knowledge of ICH GCP guidelines, ICH E3 guidelines, medical terminology and clinical trials processes.
  • Excellent time management and organisational skills.
  • Excellent oral and written communication skills.
What We Offer:

A great employee-centric culture and excellent long-term career prospects. We believe in work-life balance and offer 100% remote working options.



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