Job Description

About the Role

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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.

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Key Responsibilities

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




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- Proofread and perform quality checks on documents prepared by other team members.
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Requirements

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

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- Competitive salary package with potential for annual raises.
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- Comprehensive health insurance advantages.
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- Paid vacation and personal leave days.
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- Opportunities for professional development and skill enhancement.
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- A supportive office environment focused on quality and regulatory excellence.
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📌 Medical Writer - Clinical Documentation (Newlands)
🏢 Placements24
📍 Newlands