Clinical Study Document Specialist

2 days ago

Sydney, New South Wales, Australia beBeeMedicalWriter Full time $85,000 - $110,000
Regulatory Medical Writer Opportunity

This is a role for an experienced medical writer to coordinate, write and edit clinical study documents in the pharmaceutical and biotechnology industries.


About this Role

We are seeking a highly skilled medical writer with strong research report writing skills and experience in writing peer-reviewed journal articles.


Key Responsibilities
  • Coordinate, write and edit Investigator Brochures (IBs), Clinical Study Protocols (CSPs), Participant Information and Consent Forms (PICFs), Clinical Study Reports (CSRs) and other clinical study documents.
  • Serve as primary technical contact for assigned clinical study documents.
  • Mentor medical writers on tasks and maintain quality processes.

Qualifications, Skills and Experience
  1. Bachelor's degree in a scientific or relevant discipline.
  2. Higher degree in a scientific or relevant discipline (desired).
  3. Minimum 2 years of experience as a medical writer with prior experience in preparation of IBs, CSPs, PICFs, CSRs or other clinical trial documents.
  4. Minimum 3 years of experience in the biotechnology/pharmaceutical/clinical research industry.
  5. Strong knowledge of ICH GCP guidelines, ICH E3 guidelines, medical terminology and clinical trials processes.
  6. Knowledge of statistics and data analysis and presentation methods (desired).
  7. Knowledge of pharmacokinetics (desired).

What We Offer

A dynamic work environment and opportunities to work on diverse therapeutic areas.


Contact Us

For more information about this role please get in touch via our careers portal.

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