Louise is one of tranScrip’s senior medical affairs and pharmacovigilance scientists, with particular experience of line extensions and post-authorization referral procedures. Louise is involved in many of tranScrip’s pre and post-licensing projects across all therapeutic areas. Louise is transcrip’s Quality Director and a member of the Remuneration Committee. She has over 25 years of industry experience.
Louise has extensive experience of medical affairs, pharmacovigilance, medical and regulatory writing, medical information and staff training. Her product launch experience includes lansoprazole (Zoton), venlafaxine (Efexor) and atorvastatin (Lipitor).
Louise provides cross-functional, strategic, support for a top 3 pharma company where she holds the positions of contract Global Scientific Director and Safety Scientist. In these roles, Louise is responsible for dealing with global regulatory health authority and affiliate requests for a portfolio of products. She has been involved in several successful adult and paeditaric line extensions and has led Article 30, 31 and 45 referral procedures. She is involved in label updates and the development and assessment of Risk Management and Pregnancy Prevention Plans. She provides training and mentoring for medical staff and MSLs.
Louise has a particular interest in pharmacogenomics and is a member of BIA’s Genomics Advisory Committee.
Broad therapy area knowledge and cross-functional experience enables Louise to positively contribute to a wide range of projects including early clinical development plans and regulatory briefing documents. Louise also works with commercial teams and has developed a virtual conference booth. She has experience of promotional material development and approval, KOL identification and development, and advisory board meetings.
In addition to her industry experience, Louise spent two years as a senior editor of the British National Formulary (BNF) where she was responsible for chapters on the cardiovascular system, vaccines, malignant disease and immunosuppression. She continued to work for the BNF as a consultant over subsequent years. Prior to joining the pharmaceutical industry, Louise held several NHS roles. As a regional drug information and practice pharmacist she developed clinical treatment guidelines, provided general practitioner training and conducted prescribing audits. She produced guidelines for the management of medical emergencies by dentists and general practitioners, for the management of depression in primary care and for the primary and secondary prevention of cardiovascular disease.
Louise joined tranScrip in 2011.