Highly motivated and ambitious Medical Writer specializing in preparing documents for review by competent regulatory authorities. Research Biochemistry Masters graduate. Skilled in medical writing, research design, data collection, analysis and reporting.

Experience

  • Medical Writer

    at Aspen Pharmacare

    July 2018 - at Present

    Gauteng

     Compiling high quality clinical and non-clinical documents ensuring scientific excellence (including PI/PILs and Investigator Brochures (IBs)) for submission to regulatory authorities.  Managing and writing safety related requests from regulatory agencies and affiliates to ensure any requests are answered fully and promptly.  Writing and coordinating collaboration on Dear Healthcare Professional Letters.  Providing medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.  Ensuring document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate style guidelines.  Performing literature searches/reviews as necessary to obtain background information and training for development of documents.  Managing multiple projects with competing priorities.

  • Postgraduate Student Work

    at University of Stellenbosch

    January 2014 - July 2017

    Province of the Western Cape

     Writing and reviewing articles for peer reviewed journals.  Ad hoc genotyping for Mohair SA.  Laboratory and tutorial demonstrator during undergraduate practical and tutorial sessions in biochemistry.  Invigilation and marking of tests/assignments for undergraduate biochemistry courses at Stellenbosch University.

Education

  • Advanced Lecture Course on Nuclear Receptors and Epigenomic Mechanisms in Human Disease and Aging

    at Federation of European Biochemical Societies (FEBS)

    2017 - 2017 (1 year) Central Greece

  • Course on Liquid Chromatography – Mass Spectrometry (LCMS)

    at Central Analytical Facility (CAF)

    2017 - 2017 (1 year) Province of the Western Cape

  • Masters of Science Biochemistry (Cum Laude)

    at University of Stellenbosch

    2014 - 2016 (2 years) Province of the Western Cape

  • Diagnostics Training on the LightCycler96

    at Roche

    2014 - 2014 (1 year) Province of the Western Cape

  • Bsc. Hons Biochemistry

    at University of Stellenbosch

    2013 - 2014 (1 year) Province of the Western Cape

  • Bsc. Human Life Sciences

    at University of Stellenbosch

    2009 - 2013 (4 years) Province of the Western Cape

Languages

  • English Native

  • Afrikaans Native

Hives