About the Role
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.
Key Responsibilities
- 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.
Requirements
- 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 .
Benefits
- 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.
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Senior Medical Writer - Pharmaceutical in Kimberley employer: Placements24
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