Freelance Medical Writer

Having held a Medical Writer position within the clinical research industry for almost a decade, most recently Principal Medical Writer, I have worked on a large variety of regulatory documents across a broad range of therapeutic areas. I am a highly-experienced medical writer with the ability to convey complex scientific information in a clear and concise manner in accordance with templates, guidelines and procedures in order to deliver documents that meet specific client expectations as well as regulatory requirements. I work in a proactive, efficient and timely manner to deliver excellent quality work on time and within budget. I have an open, friendly approach and believe good communication is essential throughout all projects. I am very used to working with multi-disciplinary teams consisting of project managers, statisticians, medical monitors, regulatory experts and quality personnel.

Throughout my career, I have worked with many different clients ranging from small biotechnology companies to large pharmaceutical companies across Europe, the United States of America and Rest of World including China, Korea and Japan. I am very familiar with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines as well as European Medicines Agency (EMA) and Food and Drug Administration (FDA) requirements.