About the Role

Our client is seeking a skilled and experienced Medical Writer to support their pharmaceutical clinical trial documentation efforts. This hybrid role, based out of Kimberley , is essential for creating clear, accurate, and compliant medical and regulatory documents. You will work closely with clinical development, regulatory affairs, and project management teams to ensure that all necessary documentation for clinical trials is prepared to the highest standards. The role requires a strong understanding of medical terminology, clinical research processes, and regulatory guidelines. This position offers a great opportunity to contribute to important clinical research projects while benefiting from a flexible work arrangement. Key Responsibilities

Author, edit, and review various clinical trial documents, including clinical study protocols (CSPs), investigator brochures (IBs), clinical study reports (CSRs), and study-related informed consent forms (ICFs). Ensure all documents are scientifically accurate, medically appropriate, and compliant with regulatory requirements (e.g., ICH, FDA, SAHPRA). Collaborate with internal stakeholders to gather necessary information and ensure consensus on document content. Manage document review and approval processes,



coordinating input from multiple contributors. Maintain up-to-date knowledge of therapeutic areas and relevant medical and regulatory guidelines. Contribute to the development and maintenance of style guides and templates for clinical documentation. Requirements

Bachelor's or Master's degree in a scientific, medical, or related field. Minimum of 4 years of experience as a Medical Writer in the pharmaceutical industry, with a focus on clinical trial documentation. Thorough understanding of clinical trial phases , study designs, and regulatory submission requirements. Excellent writing, editing, and proofreading skills, with a keen eye for detail and accuracy. Proficiency in Microsoft Office Suite and familiarity with document management systems. Ability to work effectively in a hybrid workplace, managing multiple projects and deadlines. Benefits

Competitive salary and potential for annual performance bonuses. Hybrid work model providing flexibility between office and remote work. Comprehensive health, dental, and vision insurance. Generous paid time off and holiday schedule. Professional development opportunities and access to training resources.

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📌 Medical Writer - Pharmaceutical Clinical Trials (Winnipeg)
🏢 Placements24
📍 Winnipeg