Medical Writer - Clinical Study Reports

About the Role

Our client is seeking a highly skilled Medical Writer with expertise in generating Clinical Study Reports (CSRs) to join their document services team in Sheffield . This role is integral to the scientific communication strategy, ensuring that clinical trial data is accurately, clearly, and compliantly presented. You will work closely with clinical operations, biostatistics, and regulatory affairs teams to produce high-quality documentation for regulatory submissions and publications. This position offers an excellent opportunity for a talented writer to contribute to critical pharmaceutical development processes within a company that values scientific accuracy and clear communication.

Key Responsibilities

• Write, edit, and review comprehensive Clinical Study Reports (CSRs) , protocols, Investigator's Brochures, and other regulatory documents.
• Ensure all documents are scientifically accurate, medically sound, and compliant with regulatory guidelines (e.g., ICH E3).
• Collaborate effectively with internal subject matter experts (clinicians, statisticians, regulatory personnel) to gather information and ensure data integrity.
• Manage document production timelines, ensuring timely completion and delivery of high-quality outputs.
• Contribute to the development and maintenance of templates and style guides for medical writing.
• Stay updated on industry best practices, regulatory requirements, and advancements in clinical research reporting.

Requirements

• Bachelor's or Master's degree in a life science, English, Communications, or a related field.
• Minimum of 4 years of experience as a Medical Writer, with a strong focus on writing CSRs .
• Proficiency in understanding clinical trial data, statistical outputs, and regulatory requirements for submissions.
• Excellent writing, editing, and proofreading skills, with meticulous attention to detail.
• Ability to manage multiple projects simultaneously and work effectively under tight deadlines.
• Strong interpersonal and communication skills to collaborate effectively with diverse teams in Sheffield .

Benefits

• Competitive annual salary and performance bonus.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday schedule.
• Retirement savings plan with employer contributions.
• Opportunities for professional development and advanced medical writing training.