Medical Writer - Pharmaceutical Products

About the Role

Our client is seeking a skilled and experienced Medical Writer to join their dynamic communications team in Nelspruit. This hybrid role focuses on creating clear, accurate, and compliant documentation for a range of pharmaceutical products. You will be responsible for producing various medical documents, including clinical study reports, regulatory submissions, and educational materials, ensuring they meet scientific standards and regulatory requirements. This is an excellent opportunity for a proficient writer with a strong scientific background to contribute to crucial communication initiatives within the pharmaceutical industry, supporting product development and market access in a collaborative team environment.

Key Responsibilities

• Author, edit, and finalize a variety of medical documents, including clinical protocols, Investigator Brochures, clinical study reports (CSRs), and manuscripts.
• Prepare sections of regulatory submission documents, such as Investigational New Drug (IND) applications and New Drug Applications (NDAs).
• Ensure all medical documentation is scientifically accurate, clear, concise, and compliant with relevant regulatory guidelines and company standards.
• Collaborate closely with cross-functional teams, including clinical development, regulatory affairs, and R&D, to gather information and ensure document accuracy.
• Manage document review processes, incorporating feedback from multiple stakeholders efficiently.
• Stay current with therapeutic area developments and regulatory requirements affecting medical writing.

Requirements

• Bachelor's or Master's degree in a scientific or health-related field; Ph.D. is a plus.
• Minimum of 4 years of experience as a medical writer, preferably within the pharmaceutical or biotechnology industry.
• Demonstrated ability to write complex scientific documents for diverse audiences (regulatory agencies, healthcare professionals, patients).
• Thorough understanding of clinical trial processes and regulatory submission requirements.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Proficiency in using standard office software and document management systems.

Benefits

• Competitive annual salary and performance-based bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with employer contributions.
• Paid time off and professional development opportunities.
• A collaborative and flexible work environment that values scientific communication excellence.

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