Medical Writer - Clinical Study Reports

About the Role

Our client is seeking a highly skilled and experienced Medical Writer to focus on clinical study reports (CSRs) for their pharmaceutical research division. In this critical role, you will be responsible for authoring clear, accurate, and compliant CSRs based on clinical trial data. Your expertise will ensure that trial results are communicated effectively to regulatory agencies and the scientific community, supporting the drug development process.

This remote position offers the flexibility to work from anywhere while contributing to significant advancements in medicine.

• Author comprehensive Clinical Study Reports (CSRs) in accordance with ICH guidelines and regulatory requirements.
• Interpret clinical trial data and collaborate with biostatisticians and study team members to ensure accuracy.
• Prepare other regulatory documents, such as Investigator's Brochures, protocols, and study summaries.
• Ensure consistency in medical and scientific terminology across all documentation.
• Review and edit documents written by other team members, providing constructive feedback.
• Manage multiple writing projects simultaneously, meeting strict deadlines.

• Bachelor's or Master's degree in a life science, healthcare, or a related field.
• Minimum of 5 years of experience as a Medical Writer, with a strong focus on authoring CSRs.
• Thorough understanding of ICH guidelines (especially E3 for CSRs) and regulatory submission requirements.
• Proven ability to interpret complex clinical data and translate it into clear, concise written reports.
• Exceptional writing, editing, and proofreading skills.
• Experience working in a remote environment and managing projects independently.

• Competitive salary and potential for performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday schedule.
• Fully remote work arrangement allowing for excellent work-life balance.
• Opportunities for professional development and skill enhancement.
• Collaborative team environment with supportive colleagues.