Expertise and Profile

I am a highly skilled and multifaceted Medical Writer and Scientific Writer with a strong medical and scientific background across multiple therapeutic areas, complemented by international and global experience. I bring extensive expertise from both Contract Research Organizations (CROs) and the pharmaceutical industry, providing a comprehensive understanding of clinical studies, their design, protocols and reports (CSRs), and the regulations governing drug development. I have proficiency in Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and European Medicines Agency (EMA) regulations. 

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I am highly skilled in manuscript writing, peer review, and submission processes for scientific journals, as well as the development of materials for congresses and scientific meetings. This experience results from publication management with a gobal pharmaceutical company and from an advanced academic research career in the biomedical sciences. Further experience came with my freelance writing profession thereafter, and I maintain the highest standards of medical and ethical communication practices within the industry.

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I possess comprehensive expertise in biomedical scientific research, encompassing molecular and cellular techniques as well as genomics. My experience extends to a broad spectrum of genetic diseases, my own research focused on neurological disorders and obesity. This provides me with valuable insights into human biology and medicine. I have a thorough knowledge of developmental genetics, tracing the process from a single-cell embryo to a fully developed adult organism, including intricate aspects of brain development. This understanding enables me to grasp the diverse causes and mechanisms underlying various diseases and the approaches used in treating these. My deep understanding enables me to perform extensive systematic literature reviews on a wide range of clinically relevant topics that deal with complex molecular mechanisms in diagnostics and therapies. My practical experience working directly with molecular and gene therapies allows me to write about these advanced treatments with a high level of understanding and accuracy. This hands-on knowledge ensures that my written content is scientifically grounded.

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Through my work with global pharma I am further well-versed in the creation of medical information and content, including Standard Response Documents (SRDs), Frequently Asked Questions (FAQs), and information materials for both patients and healthcare professionals (HCPs). I am experienced in Medical Review involving several stakeholders and databases (iEnvision, Veeva Vault).