Lise Barbin

WORK HISTORY

EDUCATION

ABOUT LISE BARBIN

I have considerable experience in a broad range of scientific writing activities. I have been both directly involved in writing the full range of clinical and regulatory documentation as well as coordinating across a team of scientific writers and acting as the key contact for internal and external partners. I am also trilingual (French, English and German). I entered the pharmaceutical industry after my post‐doctoral fellowship position at the Pasteur Institute in Paris (France). Prior to this I completed my PhD in biochemistry at the University of Stuttgart (Germany) after finishing a chemical engineering degree from both the European Engineering Highschool in Chemistry ECPM of Strasbourg (France) and the University of Stuttgart (Germany). During my time in the pharmaceutical industry I was involved in the writing of a wide spectrum of regulatory documentation, including clinical trial applications, investigator brochures, scientific advice packages, Orphan Drug applications, safety update reports and eCTD modules. I was also involved throughout the lifecycle of these documents including submission via the centralised procedure and responses to regulatory agency questions. I have also held the position of Principal Regulatory Scientific and Medical Writer. In this role I led a team of Medical Writing professionals, worked in close collaboration with cross functional internal and external teams and experts (pharmacovigilance, biometry, clinical, non‐clinical, CMC, pharmacokinetics), and acted as a key liaison for regulatory activities. Following my time in academia and the pharmaceutical industry, I joined the consultancy company, BlueReg Pharma Consulting, where I worked for about three years, and further pursued in consultancy by joining Voisin Consulting Life Sciences (VCLS) as an Associate Director in Regulatory Science in June 2018.