Medical Writer - Pharmaceutical Dossiers

About the Role

Our client is seeking a skilled and precise Medical Writer to craft essential documentation for regulatory submissions from their remote work environment, supporting their teams near Mahikeng . This role is critical for translating complex scientific and clinical data into clear, concise, and compliant regulatory documents required for drug approval. You will work closely with cross-functional teams, including medical, clinical, and regulatory affairs, to ensure the accuracy and completeness of dossiers. The ideal candidate will possess exceptional writing abilities and a deep understanding of pharmaceutical development and regulatory processes.

Key Responsibilities

• Write, edit, and review various regulatory documents, including Investigator's Brochures (IBs), Clinical Study Reports (CSRs), Common Technical Document (CTD) modules, and briefing documents.
• Ensure all documents are scientifically accurate, ethically sound, and compliant with relevant regulatory guidelines (e.g., ICH).
• Collaborate with subject matter experts to gather necessary information and ensure the scientific integrity of documents.
• Manage document development timelines and coordinate review cycles with internal and external stakeholders.
• Maintain a high standard of clarity, grammar, and consistency in all written communications.
• Stay up-to-date with evolving regulatory requirements and medical writing best practices.

Requirements

• Advanced degree (M.S., Ph.D., Pharm.D., M.D.) in a life science, medical, or related field.
• Minimum of 4 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated expertise in preparing various types of regulatory submission documents .
• Strong understanding of clinical trial processes, drug development, and global regulatory guidelines.
• Exceptional written communication, editing, and critical thinking skills.
• Ability to work independently in a remote setting while effectively collaborating with teams that may be located near Mahikeng .

Benefits

• Competitive salary and annual performance bonus.
• Comprehensive health, dental, and vision insurance.
• Flexible remote work arrangement with support for home office setup.
• Generous paid time off and holidays.
• Opportunities for professional development, including training and conference attendance.
• A collaborative and intellectually stimulating work environment.

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