Judi Proctor

Judi is tranScrip’s Head of Medical Writing and brings over 29 years of experience in the pharmaceutical industry. She is a principal medical writer with a strong focus on clinical and regulatory writing and also serves as one of tranScrip’s senior project managers. Judi has supported products across the full development lifecycle, working on both large and orphan indications across a wide range of therapeutic areas including oncology, infectious diseases, respiratory medicine, and internal medicine. She has recently led the preparation of multiple INDs, NDAs, and MAAs through to successful submission. 

Throughout her career, Judi has developed extensive expertise in medical writing, project management, and auditing for both drugs and medical devices. She is highly experienced in the preparation of regulatory submission documents for global health authorities, including the EMA, MHRA, and FDA. Her work includes leading and authoring INDs, NDAs, MAAs, briefing books, and regulatory response documents, as well as a broad range of clinical and non-clinical regulatory documentation such as protocols, clinical study reports, investigator brochures, informed consent forms, patient information leaflets, periodic safety update reports, risk management plans, and development risk management plans. In addition to regulatory writing, Judi has significant experience producing medical affairs and scientific communications materials, including manuscripts, posters, abstracts, and advisory board reports. 

Judi has also delivered training to industry personnel on medical writing and a range of pharmaceutical topics, including ICH guidelines, Good Clinical Practice, study-specific training, and effective communication skills. She holds an MSc in Science, a Postgraduate Diploma in Science and Society, and a Postgraduate Certificate in Professional Studies in Education, and is a member of TOPRA. 

Prior to joining tranScrip, Judi held senior medical writing roles at Aptiv Solutions and Chiltern International, worked as a freelance medical writer, and previously held positions at Omnicare and Clintrials Ltd.