Medical Writer - Clinical Study Reports

About the Role

Our client is seeking an accomplished Medical Writer to join their fully remote medical affairs team, specializing in the creation of high-quality Clinical Study Reports (CSRs) and other essential regulatory documents. This role is integral to effectively communicating clinical trial results to regulatory bodies and the scientific community. You will collaborate closely with clinical development teams, statisticians, and data managers to ensure the accuracy, clarity, and completeness of documentation that underpins pharmaceutical product approvals. This is an excellent opportunity for a seasoned medical writer to contribute significantly to global health from a flexible, remote work setting, anywhere within the UK.

Key Responsibilities

• Author, edit, and finalize complex clinical study reports (CSRs), protocols, investigator brochures, and manuscripts.
• Interpret clinical data and statistical output to present findings clearly, accurately, and compliantly in written documents.
• Collaborate with internal and external stakeholders, including physicians, statisticians, data managers, and regulatory affairs personnel.
• Ensure all medical writing outputs adhere to relevant guidelines (e.g., ICH, FDA, EMA) and company standards.
• Manage multiple writing projects simultaneously, ensuring timely delivery of high-quality documents.
• Contribute to the development and maintenance of style guides and templates for medical writing.

Requirements

• Bachelor's or Master's degree in a life science, medical, or related field; PhD preferred.
• Minimum of 5 years of experience as a Medical Writer in the pharmaceutical industry , CRO, or a medical communications agency.
• Proven expertise in authoring Clinical Study Reports (CSRs) and other key regulatory submission documents.
• Strong understanding of clinical trial processes, study designs, and statistical principles.
• Exceptional writing, editing, and proofreading skills, with meticulous attention to detail.
• Ability to work independently and manage priorities effectively in a remote work environment, demonstrating excellent organizational and communication skills.

Benefits

• Competitive salary and potential for project-based bonuses.
• Fully remote work arrangement offering maximum flexibility.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and company-sponsored professional development opportunities.
• A supportive and collaborative remote team culture focused on scientific excellence and timely document delivery in the pharmaceutical domain.