General Scope & Summary

The role of a medical writer in the clinical research industry is to effectively communicate scientific and clinical information in written form. They play a crucial role in the development of clinical trial documents, such as protocols, investigator brochures, and clinical study reports. Medical writers are responsible for ensuring accuracy, clarity, and compliance with regulatory guidelines. They work closely with cross-functional teams to gather and interpret data, synthesize complex information, and create high-quality documents that contribute to the successful execution of clinical trials.

Roles and Responsibilities

• Develop and write clinical trial documents, including protocols, investigator brochures, and clinical study reports, ensuring accuracy and compliance with regulatory requirements.
• Collaborate with cross-functional teams to gather and interpret scientific and clinical data for effective communication in written form.
• Ensure clear and concise presentation of complex information, maintaining consistency and adherence to established guidelines.
• Review and edit documents for grammar, style, and clarity, ensuring coherence and logical flow of content.
• Stay updated with industry guidelines,

  regulations, and best practices related to medical writing, and incorporate them into document preparation to maintain high quality and compliance.

Qualifications

• Bachelor’s or advanced degree in life sciences, pharmacy, or a related field.
• Strong understanding of clinical research and regulatory guidelines.
• Excellent written and verbal communication skills, with a keen eye for detail
• Proficiency in scientific and medical writing, including the ability to present complex information in a clear and concise manner
• Familiarity with industry-standard software and tools used for medical writing and document preparation.