Medical Writer - Clinical Study Reports

About the Role

Our client, a dynamic pharmaceutical research organization located in Bristol , is seeking a highly skilled Medical Writer to focus on authoring Clinical Study Reports (CSRs) . You will be responsible for translating complex clinical trial data into clear, concise, and accurate documents for regulatory submissions and scientific publications. Working closely with clinical development teams, biostatisticians, and data managers, you will ensure the scientific integrity and regulatory compliance of study documentation. This role is integral to bringing new treatments to market and requires meticulous attention to detail and strong scientific writing capabilities.

Key Responsibilities

• Author comprehensive Clinical Study Reports (CSRs) for Phase I-IV clinical trials.
• Develop other regulatory documents, such as protocols, Investigator's Brochures, and briefing documents.
• Ensure all documentation is scientifically accurate, clear, concise, and compliant with regulatory guidelines (e.g., ICH).
• Collaborate with cross-functional teams, including clinicians, statisticians, and data managers, to gather necessary information.
• Review and edit documents authored by other medical writers or team members.
• Manage timelines and deliverables for assigned writing projects within the Bristol facility.

Requirements

• Bachelor's or Master's degree in a life science, medical, or related field.
• Minimum of 3 years of experience as a Medical Writer , with a strong focus on CSRs.
• Demonstrated expertise in clinical trial processes and regulatory requirements (e.g., ICH-GCP).
• Excellent writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to interpret complex scientific and statistical data.
• Strong organizational and project management skills to meet deadlines in a collaborative environment.

Benefits

• Competitive annual salary and potential for performance-based increases.
• Comprehensive medical, dental, and vision insurance.
• Pension scheme and life assurance benefits.
• Opportunities for professional development and continuing education in medical writing.
• A collaborative and supportive team environment located in central Bristol .