Clare Dixon
Independent Contractor @Bioscript Group
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WORK HISTORY
Independent Contractor @Bioscript Group
EDUCATION
University of Leeds
BSc(Hons), Pharmacology & Physiology
The Manchester Metropolitan University
HNC, Medical Laboratory Science (haematology & blood group serology)
SKILLS
ABOUT CLARE DIXON
Professional medical writer to the pharmaceutical industry for over 25 years. Working within a large pharmaceutical company and as a freelancer working with pharma, CROs and medical writing agencies, I have expertise in authoring and leading writing teams to prepare a wide range of clinical regulatory documents for both small molecules and biologicals, including- CSPs and CSRs - submission communication strategy documents - CTD clinical summaries, overviews, and associated submission documents (ISIs etc) as well as region-specific submission documents (emergency use authorization, applicability of foreign data, priority review, tabular summary of efficacy etc)- responses to health authority questions - briefing packages - patient safety narratives - IND applications - PIP/iPSP - RMPs - EU licence renewals.Experience in many therapy areas, including: respiratory (COPD, asthma), inflammation (RA, OA, nasal polyposis, gout), oncology (prostate, NSCLC, AML, CML, breast, glioblastoma, head and neck, biliary tract), pain (post-surgical, migraine), cardiovascular (acute coronary syndromes, antithrombosis, diabetes, hypertension, CKD), infection (antiviral, antibiotic, COVID-19), gastrointestinal (exocrine pancreatic insufficiency), neuroscience (major depressive disease, schizophrenia) and rare diseases (lysosomal acid lipase deficiency, hypereosinophilic syndrome, systemic sclerosis). Plus a proven ability to pick up new therapy and disease areas quickly.
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