Guaranteed clear messaging,   whatever the document and   target audience 

Experience & Qualifications

Please contact me if you would like to see my full curriculum vitae. A summary of my experience and qualifications is provided below.

Professional Experience

I honed my medical writing skills working for a medical writing agency for six years, serving clients worldwide. During that time I worked on a wide range of regulatory documents, educational pieces and marketing communications, which covered pharmaceuticals and medical devices. Training junior medical writers was also part of my role. I turned freelance in 2011.

My writing is complemented by seven years as a practising pharmacist, with experience gained in retail and hospital pharmacy, including medicines information.

Qualifications

Master of Pharmacy (Hons) – First Class grade
The University of Nottingham, UK

Foundation and Advanced certificates in Medical Writing
EMWA Professional Development Programme

Memberships

European Medical Writers Association [website]

Therapeutic Areas

I am happy to write in any therapeutic area, but recent work has included:

Oncology, haematology, endocrinology, dermatology, neurology, rheumatology, gastrointestinal disorders, musculoskeletal disorders, anorectal disorders, medical devices, oral healthcare and wound healing.

Training Record

I regularly keep my skills up-to-date by attending training courses and reading relevant publications.

Regulatory Writing

  • Clinical study protocols and protocol amendments
  • Scheduling clinical study reports and protocols
  • The CTD clinical overview
  • Periodic safety update reports
  • Paediatric investigation plans
  • EU regulatory procedures for medical writers
  • Differences between EU and US regulatory review procedures
  • e-submissions
  • Medical writing between dossier submission and drug approval
  • Responses to questions from regulatory authorities

Publications

  • Writing manuscripts
  • Critical appraisal of the medical literature
  • Citation issues in medical writing
  • CONSORT for abstracts

Statistics

  • Statistics for medical writers
  • Survival analysis and regression
  • Statistical analysis of binary data
  • Interpreting and reporting measures of risk

Other

  • Writing for medical devices
  • Writing continuing medical education (CME)
  • Writing feature articles and medical news
  • Advanced clinical study design
  • Using quality-of-life measures
  • Epidemiology for medical communicators
  • Communication in multidisciplinary teams
  • Word usage, writing skills