Clinical Documentation Specialist

2 weeks ago

Adelaide, South Australia beBeeRegulatory Full time $100,000 - $145,000
Regulatory Medical Writer Opportunity

As a seasoned medical writer, you will play a pivotal role in the development and editing of clinical documents for the pharmaceutical and biotechnology industry. This position requires strong technical skills and attention to detail to ensure high-quality deliverables.

Responsibilities:
  • Develop and coordinate clinical study protocols, investigator brochures, participant information sheets, and clinical study reports.
  • Serve as primary technical contact for cross-functional teams, mentor junior writers, and uphold quality standards.
Requirements:
  • Bachelor's degree in a scientific or relevant field.
  • Minimum 2 years of experience in medical writing, including clinical trial documentation.
  • Strong background in the biotech/pharma/clinical research industry.
  • Excellent report-writing skills and experience with peer-reviewed publications.
  • Proficiency in MS Office and knowledge of ICH GCP, ICH E3 guidelines, medical terminology, and clinical trial processes.
Key Skills:
  • Regulatory medical writing
  • Clinical trial documentation
  • Medical writing software
  • Peer-reviewed publications
  • MS Office proficiency

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