Senior Medical Writer - Regulatory Documents

About the Role

Our client is seeking an accomplished Senior Medical Writer to join their high-performing regulatory affairs team in Sheffield . This role is integral to the clear and accurate communication of complex scientific and clinical data for regulatory submissions and publications. You will be responsible for writing, editing, and managing a variety of essential regulatory documents, ensuring compliance with all relevant guidelines and company standards. This position offers a challenging and rewarding opportunity to contribute to the success of pharmaceutical products by translating scientific information into compelling and compliant documentation, with a flexible hybrid work arrangement.

Key Responsibilities

• Author, edit, and manage the development of key regulatory documents, including clinical study reports (CSRs), Investigator's Brochures (IBs), and briefing documents.
• Ensure all documents are scientifically accurate, medically sound, and compliant with relevant regulatory guidelines (e.g., ICH).
• Collaborate effectively with cross-functional teams, including clinical operations, biostatistics, and regulatory affairs, to gather information and feedback.
• Manage document timelines and production processes, ensuring timely delivery of high-quality submissions.
• Contribute to the development and maintenance of company style guides and templates for regulatory documents.

Requirements

• Bachelor's or Master's degree in a life science, medical, or related field.
• Minimum of 6 years of experience as a Medical Writer within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in writing and managing various regulatory documents .
• Thorough understanding of clinical trial processes and ICH-GCP guidelines.
• Exceptional writing, editing, and communication skills, with meticulous attention to detail.

Benefits

• Competitive salary and comprehensive benefits package.
• Hybrid working model offering flexibility between home and our Sheffield office.
• Opportunities for professional growth and continuing medical education.
• Collaborative and supportive team environment.
• Contribute to the development and regulatory success of innovative medicines.