About the Role
Our client is seeking a highly skilled and detail-oriented Medical Writer to produce high-quality clinical documentation, focusing on Clinical Study Reports (CSRs) , for their operations in East London . This role is integral to the clinical development process, ensuring that study results are accurately, clearly, and compliantly communicated to regulatory authorities and the scientific community. You will collaborate closely with clinical scientists, biostatisticians, and regulatory affairs specialists to synthesize complex data into comprehensive reports. This is an excellent opportunity for a proficient writer to contribute to vital pharmaceutical research and development efforts within a supportive and professional environment. We are looking for a candidate with a strong scientific background and exceptional writing capabilities.
Key Responsibilities
- Author, edit, and finalize various clinical documents, with a primary focus on Clinical Study Reports (CSRs) .
- Ensure all documents are prepared in accordance with relevant regulatory guidelines (e.g., ICH E3) and company SOPs.
- Collaborate effectively with cross-functional teams, including clinicians, statisticians, and regulatory experts, to gather necessary information.
- Review and interpret clinical and statistical data to accurately reflect study findings.
- Manage document timelines and deliverables, ensuring projects are completed on schedule.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices for medical writing.
Requirements
- Bachelor's or Master's degree in a life science, health science, or related field.
- Minimum of 4 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
- Demonstrated experience in writing Clinical Study Reports (CSRs) and other clinical regulatory documents.
- Thorough understanding of ICH guidelines, especially ICH E3 for CSRs, and other relevant regulatory requirements.
- Exceptional scientific writing, editing, and proofreading skills.
- Ability to work independently and manage multiple projects efficiently in the East London office.
Benefits
- Competitive annual salary and performance-related bonus opportunities.
- Comprehensive medical, dental, and vision insurance coverage.
- Generous annual leave and company-paid holidays.
- Support for professional development, including writing courses and conferences.
- A collaborative team environment that values scientific accuracy and regulatory compliance in the Eastern Cape .
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Medical Writer - Clinical Study Reports employer: Placements24
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