Medical Writer - Clinical Documentation

About the Role

Our client is seeking a skilled Medical Writer specializing in clinical documentation to join their team in Nelspruit. This hybrid role involves preparing high-quality, accurate, and compliant clinical study documents, ensuring clear communication of scientific and medical information. You will work closely with clinical operations, regulatory affairs, and R&D teams to produce essential documents for clinical trials and regulatory submissions. This position offers the flexibility of remote work combined with the necessity of on-site collaboration, ideal for a writer who excels in clear, concise scientific communication.

• Author, edit, and review clinical study protocols, clinical study reports (CSRs), investigator brochures, and other regulatory documents.
• Ensure all documentation adheres to relevant regulatory guidelines (e.g., ICH, FDA, EMA) and company standards.
• Collaborate with subject matter experts to gather information and ensure scientific accuracy.
• Manage document review cycles, incorporating feedback from stakeholders in a timely manner.
• Contribute to the development of standard templates and style guides for clinical documentation.
• Maintain up-to-date knowledge of medical and scientific terminology and regulatory requirements.

• Bachelor's or Master's degree in a life science, pharmacy, or related field.
• Minimum of 3 years of experience as a Medical Writer, with a focus on clinical documentation within the pharmaceutical or biotech industry.
• Proficiency in authoring various types of clinical documents according to ICH-GCP standards.
• Excellent understanding of clinical trial processes and regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills, with a strong command of scientific language.
• Ability to manage multiple projects and meet tight deadlines in a hybrid work setting.

• Competitive annual salary and potential performance incentives.
• Comprehensive health and wellness benefits.
• Flexible hybrid work arrangement balancing remote and office work.
• Opportunities for professional development and training.
• Collaborative team environment in a scenic location.
• Contribution to impactful clinical research initiatives.