PGC-PSE, PGDipSciSoc, MSc
Head of Medical Writing
Judi is a principal medical writer who has worked in the pharmaceutical industry for over 28 years. She has extensive experience in medical writing, project management and auditing, for both drugs and devices. Judi is a seasoned writer producing regulatory submission documents including INDs, NDAs, MAAs, briefing books and response documents, for the EMA, MHRA and FDA and writing and leading a wide range of clinical and non-clinical regulatory documents including protocols, CSRs, IB, ICFs, PILs, PSURs, RMPs and DDRMPs. In addition, Judi is highly experienced in producing medical affairs and medical communications documents including manuscripts, posters, abstracts and scientific advisory board reports.
Her expertise covers 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.
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.
She holds an MSc in Science, a Postgraduate Diploma in Science and Society and a Postgraduate Certificate in Professional Studies in Education.
Judi is a member of TOPRA.
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