Judi is Head of tranScrip’s medical writing department and has been with tranScrip for over 8 years. She has over 25 years medical writing experience working with a number of mid to large CROs.
Judi has a broad range of expertise in medical writing for both drugs and devices, for the entire product life-cycle for large and orphan indications across a wide range of therapeutic and development functional areas, including oncology, infectious diseases, respiratory and internal medicine and has recently been involved in the preparation of a number of MAAs, and INDs. Judi has lead the writing of a number of INDs, NDAs and MAAs to successful submission.
Judi has previously worked with Mithra, providing medical writing support for the Esterol (E4) COVID-19 programme, including regulatory strategy and communications and publications.
Judi has extensive experience in writing, auditing and project managing a wide range of regulatory documents including protocols, CSRs, IB, ICFs, PILs, PSURs, RMPs and DDRMPs, regulatory submission documents, as well as medical affairs and medical communications documents including scientific advisory board reports, manuscripts posters and abstracts.
Judi also has experience of training industry personnel in medical writing and a variety of other pharmaceutical topics, including ICH, GCP, study specific training and communication skills.
Judi holds an MSc in Science, a Postgraduate Diploma in Science and Society and a Postgraduate Certificate in Professional Studies in Education.