Medical Writer - Clinical Documentation

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

About the Role

Our client requires a skilled Medical Writer to focus on clinical documentation for their operations in Queenstown. This role is essential for creating clear, accurate, and compliant documentation related to clinical trials and product development. You will work closely with scientific and clinical teams to translate complex data into accessible documents for regulatory submissions, internal use, and publication. This position is based in our Queenstown office, providing a central hub for collaboration and documentation management.

Key Responsibilities

• Author, edit, and review various clinical documents, including clinical study reports (CSRs), protocols, and Investigator's Brochures.
• Ensure all documentation adheres to regulatory guidelines (e.g., ICH, FDA, EMA) and client standards.
• Collaborate with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs.
• Manage document timelines and ensure timely delivery of high-quality documents.
• Contribute to the development and maintenance of document templates and style guides.
• Proofread and perform quality checks on documents prepared by other team members.

Requirements

• Bachelor's degree in a scientific, medical, or technical writing discipline.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Proficiency in writing clinical study reports (CSRs) and other regulatory documents.
• Strong understanding of clinical trial processes and pharmaceutical development.
• Exceptional writing, editing, and proofreading skills.
• Ability to work effectively in a team environment within our Queenstown office.

Benefits

• Competitive salary package with potential for annual raises.
• Comprehensive health insurance benefits.
• Paid vacation and personal leave days.
• Opportunities for professional development and skill enhancement.
• A supportive office environment focused on quality and regulatory excellence.