Clinical Medical Writer: CSR & Regulatory Docs (Queenstown)

Placements24; Newlands; On-site; AUD 56,000 - 89,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Paid vacation

Professional development

Supportive office environment

Job summary

Placements24 is seeking a skilled Medical Writer in Queenstown to focus on clinical documentation for regulatory submissions and product development. You will translate complex data into clear, compliant documents for CSRs, protocols, and investigators' brochures, working closely with scientific and clinical teams.

The role requires a Bachelor’s degree in a scientific or medical field and at least 3 years of medical writing experience in pharma or biotech.

Qualifications

• Bachelor's degree in a scientific, medical, or technical writing discipline.
• 3+ years of experience as a Medical Writer in pharma/biotech.
• Proficiency in writing CSRs and regulatory documents.
• Strong understanding of clinical trial processes and pharmaceutical development.

Responsibilities

• Author, edit, and review clinical documents (CSRs, protocols, Investigator's Brochures).
• Ensure documentation adheres to regulatory guidelines (ICH, FDA, EMA).
• Collaborate with clinical operations, biostatistics, and regulatory affairs.
• Manage document timelines and ensure timely delivery of high-quality documents.
• Contribute to templates and style guides; perform quality checks on others' documents.

Skills

Medical Writing

Regulatory Writing

Team Collaboration

Editing

Education

Bachelor's degree in science/medical writing

Job description

Placements24 is seeking a skilled Medical Writer in Queenstown to focus on clinical documentation for regulatory submissions and product development. You will translate complex data into clear, compliant documents for CSRs, protocols, and investigators' brochures, working closely with scientific and clinical teams.

The role requires a Bachelor’s degree in a scientific or medical field and at least 3 years of medical writing experience in pharma or biotech.