The desire to share knowledge and provide mutual support are what makes the Bioforum MW team so special and successful. The medical writers at Bioforum are a diverse group of people, brought together by a common love of organizing vast amounts of data into coherent and cohesive documents for the client. Medical writing to me brings together in one package everything that I find exciting and enjoy doing. In addition, I am perpetually curious about the world of biology and specifically, new advances in the field of biomedical sciences. ![]() I have always enjoyed the writing process, working and molding a document to bring it to the highest possible level of precision and clarity. ![]() My professional career as a scientific writer and editor has taken me through academic writing, writing and prosecuting patents, through to the pharma industry, in which I have wide-ranging experience in the preparation of global regulatory submission documents (CTDs), particularly CMC documentation. I hold a PhD in molecular virology from the Hebrew University of Jerusalem, Israel. At Bioforum, I feel I can do what I love with people that like to be well-prepared and show deep passion for their work and strong togetherness. Bioforum’s strength lies within its team, the flexibility given to people to be employees without compromising their personal lives, the eagerness of the team members to do their best each day, the opportunities the team is given for development through internal training and support, and the team’s diversity. There is an opportunity to learn something every day by writing new types of documents, getting involved in projects with novel medications or diseases outside of my areas of expertise, but also through trying to keep abreast of all the changes in the regulations underpinning clinical trials. I love how the work itself is very structured and organized, but the topics are ever-changing. After all these years, my enthusiasm for being in this profession continues to grow. I am an expert in authoring protocols, CSRs and scientific journal articles. I worked as a medical writer in a US-based CRO for 2 years and in a Greece-based CRO for nearly 9 years before joining Bioforum in 2021. I hold a PhD in biology and an MSc in toxicology from George Washington University, USA. My book on the subject has recently been published worldwide. I write and edit manuscripts and give workshops to medical doctors and scientists on this subject. In addition to regulatory documents, I am an expert in writing scientific journal articles. I am experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management, with the aim of producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines. My expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents including investigator’s brochures and summaries of efficacy and safety. I am experienced in managing medical writing projects for early and late phase product development. Since then, I have been working as an independent instructor and consultant of medical writing. I have been a medical writer since 2009, and worked as a medical writer and medical writing team leader at Teva until 2014. I hold a PhD in cell, molecular and developmental biology from Tufts University, USA. ![]() We work in collaboration with the clinical, regulatory and statistical experts to develop the most accurate and clear reports and summaries, paying meticulous attention to detail while taking care to provide the reader with a holistic understanding of results. We have experience in writing the Module 2.7.1 Summary of Biopharmaceutic Studies, Module 2.7.2 Summary of Clinical Pharmacology, Module 2.7.3 Summary of Clinical Efficacy and Module 2.7.4 Summary of Clinical Safety, as well as reports of integrated analyses (Module 5.3.5.3 Integrated Summary of Efficacy and Integrated Summary of Safety) and clinical overviews. We write reports that are ICH E3-compliant (or ISO 14155 for medical device, as applicable) for studies from Phase I (including clinical pharmacology studies), through Phase II and III (clinical efficacy and safety) to Phase IV (including safety registry and post-marketing observational studies). Bioforum writers have vast experience in writing clinical study reports and CTD summaries in a wide array of therapeutic areas.
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