Senior Medical Writer - Pharmaceutical

Our client is seeking a highly skilled Senior Medical Writer to join their expanding regulatory affairs and communications team in Kimberley . This crucial role involves crafting clear, accurate, and compliant regulatory and scientific documents that support drug development and registration globally. You will be responsible for producing a wide range of documents, including clinical study reports, regulatory submission documents, and scientific publications.

The ideal candidate possesses exceptional writing abilities, a thorough understanding of pharmaceutical sciences, and the expertise to translate complex scientific data into accessible and compelling narratives for diverse audiences.

• Author, edit, and review a variety of regulatory and scientific documents, including Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Ensure all documents meet regulatory requirements (e.g., ICH, FDA, EMA, SAHPRA) and internal style guidelines.
• Collaborate closely with clinical development, regulatory affairs, biostatistics, and medical affairs teams to gather information and ensure accuracy.
• Manage document timelines and deliverables effectively, coordinating input from multiple contributors.
• Contribute to the development of medical communication strategies and publication plans.
• Maintain up-to-date knowledge of therapeutic areas, regulatory guidelines, and medical writing best practices.

• Bachelor's or Master's degree in a life science, pharmacy, medicine, or a related field.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated experience in writing clinical study reports and regulatory submission documents.
• Excellent command of English language, grammar, and scientific terminology.
• Proficiency with Microsoft Office Suite and experience with document management systems.
• Strong understanding of drug development processes and regulatory requirements is critical for success in this role in Kimberley .

• Competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance benefits.
• Generous paid time off and holidays.
• Opportunities for professional development and continuing education.
• Flexible remote work arrangements offering excellent work-life balance.