Technical Writer

General role description

Technical Writers in Contract Research Organisations (CROs) and the pharmaceutical, biotechnology, and medical device industries prepare clear, accurate, and compliant documentation to support clinical research, regulatory submissions, and product development. They translate complex scientific or technical information into structured documents that meet industry guidelines, regulatory requirements, and stakeholder needs. Their work is critical to ensuring clarity, consistency, and quality across a range of materials, including protocols, study reports, and user manuals.

Key tasks and responsibilities

  • Write and edit technical and scientific documents such as clinical study protocols, investigator brochures, regulatory submissions, and standard operating procedures (SOPs)
  • Translate complex information into clear, concise, and accessible formats for different audiences
  • Ensure documents comply with applicable regulatory standards (e.g. ICH-GCP, TGA, FDA, EMA)
  • Collaborate with scientists, clinicians, regulatory teams, and project managers to gather and verify information
  • Review and revise documents based on stakeholder feedback and quality assurance processes

Workplace settings

  • Pharmaceutical, biotechnology and medical device companies
  • Contract Research Organisations (CROs)

Required qualifications

  • A degree in life sciences, health sciences, pharmacy, biomedical science, or a related field
  • Qualifications in communication, writing, or journalism are also valued, especially when paired with scientific knowledge

Other notable requirements

  • Excellent written communication and editing skills
  • Strong attention to detail and understanding of scientific language and terminology
  • Familiarity with document templates, formatting standards, and version control
  • Ability to meet deadlines and manage multiple writing projects at once
  • Knowledge of clinical research or regulatory documentation processes

Common entry points

Common next roles

Regulatory Affairs Specialist

Senior Technical Writer

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