Medical Writer - Clinical Study Reports

About the Role

Our client is seeking a highly proficient Medical Writer to join their team in a fully remote capacity, contributing to their global pharmaceutical operations. This role focuses on producing high-quality clinical study reports (CSRs), protocols, and other regulatory documents that accurately and effectively communicate clinical trial data. You will work closely with clinical development teams, statisticians, and project managers to ensure scientific accuracy, regulatory compliance, and clarity in all written documentation. This remote position is ideal for an experienced writer seeking a challenging and rewarding role.

Key Responsibilities

• Author clear, concise, and scientifically accurate Clinical Study Reports (CSRs) .
• Develop and edit clinical trial protocols, amendments, investigator brochures, and clinical summaries.
• Ensure all documentation meets regulatory requirements (e.g., ICH guidelines) and company standards.
• Collaborate with cross-functional teams to interpret clinical data and prepare comprehensive study reports.
• Review and revise documents drafted by other team members or external vendors.
• Maintain a high level of understanding of the assigned therapeutic areas and clinical development processes.

Requirements

• Bachelor's or Master's degree in a scientific or medical discipline.
• Minimum of 3-5 years of experience as a Medical Writer in the pharmaceutical or biotechnology industry.
• Demonstrated experience in writing CSRs, protocols, and other regulatory submission documents.
• Thorough understanding of ICH guidelines and regulatory submission processes.
• Exceptional writing, editing, and proofreading skills with meticulous attention to detail.
• Ability to manage multiple projects effectively in a remote setting, meeting tight deadlines.

Benefits

• Competitive annual salary.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan.
• Generous paid time off and holidays.
• Fully remote working arrangement, providing flexibility and work-life balance, supporting our operations for clients in Nottingham and globally.