Senior Clinical Documents Specialist

6 days ago


Melbourne, Victoria, Australia beBeeMedicalWriter Full time $80,000 - $120,000

Job Title: Medical Writer II

We are seeking an experienced medical writer to join our team. The role requires the coordination, writing and editing of various clinical study documents.

Broad Purpose
  • Investigator Brochures (IBs)
  • Clinical Study Protocols (CSP)
  • Participant Information and Consent Forms (PICFs)
  • Clinical Study Reports (CSRs)

The successful candidate will be responsible for mentoring junior writers and maintaining quality processes.

Requirements
  • Ordinary degree in a scientific or relevant discipline
  • Higher degree in scientific or relevant discipline (desirable)
  • Minimum 2 years of experience as a MW 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 guideline, ICH E3 guideline, medical terminology and clinical trials processes
  • Knowledge of statistics and data analysis and presentation methods (desirable)
  • Knowledge of pharmacokinetics (desirable)
  • Excellent time management and organisational skills
  • Excellent oral and written communications skills
  • Demonstrated initiative, reliability and ability to work unsupervised
  • Willingness to work in, and be supportive of, a positive and dynamic team culture
  • Intermediate to advanced skills in MS Office suite
  • Mentoring/leadership experience


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