Senior Regulatory Medical Content Specialist

2 days ago

Sydney, New South Wales, Australia beBeeScientific Full time $90,000 - $123,000
Medical Writer II Opportunity

We are seeking an experienced regulatory medical writer to contribute to the preparation of high-quality clinical trial documents.

Key Responsibilities:
  • Develop and edit clinical trial documentation, including IBs, CSPs, PICFs, CSRs, and other relevant documents.
  • Collaborate with cross-functional teams to ensure document quality and consistency.
  • Stay up-to-date with industry regulations, guidelines, and best practices.
Required Skills and Qualifications:
  1. Ordinary degree in a scientific or relevant discipline.
  2. Higher degree in scientific or relevant discipline (desired).
  3. Minimum 2 years of experience as a medical writer with prior experience in preparation of clinical trial documents.
  4. Minimum 3 years of experience in the biotechnology/pharmaceutical/clinical research industry.
  5. Strong research report writing skills and/or demonstrated experience in writing peer-reviewed journal articles.
  6. Knowledge of ICH GCP guideline, ICH E3 guideline, medical terminology, and clinical trials processes.
  7. Excellent time management and organizational skills.
  8. Excellent oral and written communication skills.
  9. Demonstrated initiative, reliability, and ability to work independently.
What We Offer:

A great employee-centric culture, excellent long-term career prospects, and a commitment to work-life balance.

You will be joining a high-performing, supportive team of experienced medical writers and editors.

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