Medical Writer - Clinical Documentation

About the Role

Our client is seeking a skilled and precise Medical Writer specializing in clinical documentation to join their team, covering the Plymouth area. This role is central to translating complex scientific and clinical data into clear, accurate, and compliant documents required for regulatory submissions and publications. You will work collaboratively with research scientists, clinicians, and regulatory affairs specialists to produce high-quality documents such as clinical study reports (CSRs), protocols, and regulatory submission dossiers. This is an excellent opportunity to leverage your writing expertise in the dynamic pharmaceutical and medical research field within Devon , operating with flexibility.

Key Responsibilities

• Author, edit, and finalize various clinical and regulatory documents, including Clinical Study Reports (CSRs), Investigator's Brochures, and study protocols.
• Ensure all documentation adheres to regulatory guidelines (e.g., ICH, FDA, EMA) and company standards.
• Collaborate effectively with internal and external stakeholders, including medical experts, biostatisticians, and regulatory affairs personnel.
• Review and interpret complex scientific and clinical data to ensure accuracy and clarity in written communications.
• Manage document timelines and project deliverables, ensuring timely completion of writing assignments.
• Contribute to the development and maintenance of document templates and style guides.

Requirements

• Bachelor's or Master's degree in a scientific, medical, or related field.
• Proven experience as a Medical Writer , with a strong focus on clinical documentation and regulatory submissions.
• In-depth knowledge of ICH guidelines, GCP, and regulatory requirements for pharmaceutical development.
• Exceptional writing, editing, and proofreading skills, with a keen eye for detail.
• Ability to interpret complex scientific and statistical data.
• Experience working in a pharmaceutical, biotechnology, or Contract Research Organization (CRO) environment is essential.

Benefits

• Competitive salary and performance-based bonus opportunities.
• Hybrid working model providing a blend of office and remote flexibility.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holiday allowance.
• Professional development and training opportunities to enhance skills.