A Hampshire (UK) based Medical and Regulatory Affairs Writer with a Bachelor’s Degree in Veterinary Medicine and Surgery, and previous experience in academic research and clinical practice. Worked as part of transition team after takeover of Fort Dodge Animal Health by Pfizer, followed by one year working in a Medical Communications and Education Consultancy. Now seeking freelance and contract Regulatory Affairs and Pharmacovigilance workm, as well as looking to diversify into other areas of writing, including the Technical and Motor Industry fields.
Well practiced 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.
- Five years’ experience of writing and editing regulatory documents, communications and presentations: part of nine years’ overall experience of the pharmaceutical industry, including work on the Sales Team and with the Technical Services Team.
- Experienced at writing summary reports, and at editing those of other team members.
- In Pharmacovigilance role wrote Periodic Safety Update Reports, Bridging Reports and Safety/Clinical Expert statements covering a wide range of pharmaceutical product groups. Experience of writing and updating SOPs, and of training colleagues in pharmacovigilance and adverse reaction reporting.
- Coordinated preparations for the Pharmacovigilance Inspection of FDAH UK by the Veterinary Medicines Directorate, oversaw Inspection and initiated follow-up: received glowing report of Company’s preparedness from the VMD Inspection Team.
- After overseeing a small scale clinical trial at the Moredun Research Institute, was made the company’s main UK contact for a larger scale multi-centric double-blind clinical trial of a novel feline vaccine. Responsible for submitting the application for an Animal Test Certificate, and liaising with both the Veterinary Medicines Directorate and the Clinical Research Organisation on behalf of the company.
- Proficient in all MS-Office applications including Microsoft Word, Excel, and PowerPoint as well as use of Access-based databases.
- Equally competent working alone or as part of a team, including working remotely and at hours to suit the needs of a global company.
- Hon Sec of the Association of Veterinarians in Industry, member of The Organisation of Professionals in Regulatory Affairs – and formerly on the steering committee of the organisation’s PV Special Interest Network, member of the European Medical Writers Association (EMWA).
- Studying for EMWA Professional Development Programme Foundation Certificate. Six out of eight modules completed: ‘Subject Narratives for Clinical Study Reports’, ‘From Protocol to Study Report: What’s In Between?’, ‘Publication Planning’, ‘Targeting Your Audience’, ‘Basic Epidemiology for Medical Communicators’ and ‘The Patient Information Leaflet’. Also a not-for-credit module on ‘Publication Ethics’. Working towards two modules to be completed in May 2013.
- Publication in The Write Stuff (the journal of the European Medical Writers Association): a short report on the Lisbon Conference in 2010, and Medical writing for the veterinary pharmaceutical industry, take two: Pharmacovigilance in Vol. 20, No. 2, 2011.
Additional Information: Volunteering
- I run a local Brownie Unit, and take part in regular training and leadership events provided by Girlguiding UK to further enhance my people management and teambuilding skills.
- I am also involved in Community Action projects through Broadlaw Walk Community Space, including helping with the Summer and Christmas Fairs, and the new Mosaic Project to involve local residents in designing a new outdoor space around the new flats and shopping precinct.