Medical Writer - Regulatory Documentation

About the Role

Our client is seeking a skilled and experienced Medical Writer to produce high-quality regulatory documentation for their pharmaceutical products from their base in Paarl. You will be responsible for authoring, editing, and reviewing a variety of documents, including clinical study reports, regulatory submission documents, and scientific publications. This role demands exceptional writing abilities, a thorough understanding of scientific principles, and the capacity to translate complex data into clear, concise, and compliant text.

Key Responsibilities

• Author, edit, and finalize various regulatory documents, such as clinical trial protocols, Investigator's Brochures (IBs), Clinical Study Reports (CSRs), and Common Technical Document (CTD) modules.
• Ensure all documents are scientifically accurate, grammatically correct, and adhere to company style guides and relevant regulatory agency guidelines.
• Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and statistics, to gather information and ensure document completeness.
• Review and revise documents based on internal and external stakeholder feedback.
• Maintain knowledge of therapeutic areas, relevant guidelines, and industry best practices for medical and regulatory writing.
• Manage document timelines and deliverables effectively to meet submission deadlines.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Life Sciences, Pharmacy, Medicine). A Master's or Ph.D. is an asset.
• Minimum of 3 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry, with a focus on regulatory documentation.
• Proven ability to write clear, concise, and scientifically accurate documents for diverse audiences.
• Strong understanding of clinical trial processes, pharmaceutical development, and regulatory requirements.
• Proficiency in standard office software and experience with document management systems.
• Excellent organizational skills and the ability to manage multiple projects under tight deadlines.

Benefits

• Competitive salary with potential for performance-based increases.
• Comprehensive medical, dental, and vision coverage.
• Generous paid time off and flexible working hours.
• Opportunities for professional growth and training in medical writing.
• A supportive and collaborative remote working environment.

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