Lioness Writing Ltd was founded in 2010 by Directors Elsa and Mark Lewis. The company provides medical writing services for regulatory documents to the Pharmaceutical Industry.
Elsa Lewis has more than 20 years experience in medical writing and has worked as a medical writer with small, medium and large Pharma and Contract Research Organisations. She has led several successful key regulatory submissions. Click here for LinkedIn profile
Debbie Rogers has worked with Lioness Writing Ltd since 2015 as Assistant Medical Writer and Technical Editor on various Medical Writing and Communication projects, e.g. slide set design, promotional and training material, narratives, quality control of clinical documents, standard operating procedures.
Mark Lewis has worked with Lioness Writing Ltd since 2021 as Medical Writer. He has a well proven scientific background, having been a Team Leader in a leading pharmaceutical company, considerable pharmacokinetics and drug metabolism experience and has contributed to various nonclinical reports and authored scientific publications.
Claire Delbridge has worked with Lioness Writing Ltd since 2016 as Associate Medical Writer and Publishing Assistant on Medical Writing e.g. authoring protocols, clinical study reports, narratives, Investigator Brochures, Briefing Books, literature search reports and other clinical documents. Other publishing activities include full book layout and technical editing.
Juliet Lewis has worked with Lioness Writing Ltd since 2020 as a publishing assistant. She has experience with writing safety narratives, literature reviews and quality control of a wide variety of documents. Click here for LinkedIn profile
Therapeutic Areas:
Oncology, Neurology, Fertility, Sexual Health, Endocrinology, Primary Care, Devices, Paediatrics, Gastrointestinal health, Pain, Neuroscience, Vaccines, Generics, Cardiovascular, Metabolic Diseases, Orphan Drugs, Biologicals and Respiratory Diseases.
Medical Writing documents:
- Common Technical Dossier Module 2.7 and 2.5 including Integrated Summaries of Safety and Efficacy and management of Module 5.
- Clinical Study Reports and Investigator Brochures, narratives and other summary documents.
- Paediatric Investigation Plans and Regulatory Responses to Questions.
- Publication assistance.
- Successful global submission experience including documents for regulatory approval in US, Europe, China and worldwide.
- Literature searches and high-quality reports.
- Writing and publishing submission-ready outputs.
- Experience with several different document management systems.
- Training provision for Medical Writers.
- Experience in therapies at Phase I to Phase IV, pre and post-marketing.
- Medical summary documents.
- Bulletin articles for professional organisations.
- Experience with a wide range of IT software including elements of Microsoft Office (Word, Project, Excel, Powerpoint, Access etc), Acrobat Pro, SAS outputs, ISI Toolbox, drawing and photograph processing packages.
- Documentum and other document management systems, e.g. Veeva.