Freelance Writer and Editor @ Jasmine Writing Services
Senior Medical Writer @ Strategen
Sheffield High School
A West Yorkshire (UK) based Regulatory Affairs/Pharmacovigilance Professional and Medical Writer with a Bachelor’s Degree in Veterinary Medicine and Surgery, and previous experience in academic research and clinical practice. Able to diversify into other areas of writing, including the Technical and Motor Industry fields. Well practised at writing Safety Reports, Risk Assessments and other highly detailed documents
A West Yorkshire (UK) based Regulatory Affairs/Pharmacovigilance Professional and Medical Writer with a Bachelor’s Degree in Veterinary Medicine and Surgery, and previous experience in academic research and clinical practice. Able to diversify into other areas of writing, including the Technical and Motor Industry fields. Well practised at writing Safety Reports, Risk Assessments and other highly detailed documents for applications to National Authorities as well as producing less specialised summary documents for medical and veterinary professionals, and lay users of the product ranges. Proficient in the use of Access-based databases for data storage, retrieval and analysis, and at writing reports based on these data.
Specialties: medical writing, pharmacovigilance, regulatory affairs, veterinary pharmaceuticals
Regulatory Affairs Officer @ From June 2014 to Present (1 year 7 months) Freelance Writer and Editor @ Available for freelance, contract and part-time work. Particular interests include veterinary medicine, pharmacovigilance and regulatory affairs. From April 2013 to Present (2 years 9 months) Senior Medical Writer @ Wring and editing of manuscripts for submission to peer-reviewed journals, as well as copy for range of medical education materials in wide range of disease areas including rheumatology, oncology, dermatology, and urology. Liaison with clients and Key Opinion Leaders for development of written materials and the planning of educational meetings. Production of meeting reports based on written transcripts and audio recordings. Supervision and mentoring of Associate Medical Writers. Editorial input on new in-house training materials and Standard Operating Procedure documentation. From March 2012 to March 2013 (1 year 1 month) Freelance Writer @ Contemplating taking on some freelance work while deciding on my next permanent career direction. From 2011 to March 2012 (1 year) Biologicals Registration Manager (Pharmacovigilance) @ Responsible for regulatory and pharmacovigilance oversight of vaccine and pharmaceutical ranges in UK, Ireland and the EU. Liaised with National and EU-wide Authorities, including organising and overseeing the routine inspection of company premises by representatives of the UK Authorities. Coordination of US and European Research and Development groups. Provided regulatory input and critical analysis of marketing materials to ensure compliance with industry codes of conduct. Represented the company on National Office of Animal Health committees.
• In Regulatory Affairs role wrote and edited documentation for Marketing Authorisation applications, variations, and renewals, including line extensions, copycat applications and updates to SPCs and product literature.
• In Pharmacovigilance role, wrote Periodic Safety Update Reports, Controlled Safety Data Sheets, as well as Risk Assessments, and Clinical/Safety Expert Statements for Regulatory Affairs submissions.
• As Deputy QPPV for Fort Dodge Animal Health, was responsible for writing and updating SOPs as well as training local staff across EU in Regulatory and Pharmacovigilance requirements and procedures. From November 2003 to September 2011 (7 years 11 months)
BVM&S, Veterinary Medicine and Surgery @ The University of Edinburgh From 1990 to 1995 Sheffield High School From 1981 to 1990 Gina Dungworth is skilled in: Medical Writing, Pharmacovigilance, Pharmaceuticals, Regulatory Affairs, Veterinary, Writing, Vaccines, Animal Health, Clinical Trial Management, Veterinary Medicine, Pharmaceutical Industry, PSUR Writing, Copywriting, Pharmaceutics
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