Arunon Sivananthan
Junior Medical Writer @Caidya
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WORK HISTORY
Junior Medical Writer @Caidya
As a Regulatory Medical Writer at Caidya, I am an integral part of project and study teams, contributing to the production of high-quality regulatory and clinical documentation across various therapeutic areas. My role involves drafting, editing, and reviewing essential documents such as clinical study protocols, informed consent forms, investigator brochures, and clinical study reports. These documents are crucial for regulatory submissions and help ensure that clinical trials are conducted in compliance with regulatory standards and ethical guidelines.Working closely with cross-functional teams, I ensure that all documents meet internal and external quality standards and comply with industry guidelines. I am responsible for maintaining consistency and accuracy in the presentation of clinical data, while also ensuring that documents are clear, concise, and aligned with regulatory requirements. This involves performing quality checks for data accuracy, referencing, and adherence to templates and style guides.In this role, I am constantly expanding my expertise in medical and regulatory writing through hands-on experience and ongoing training. I collaborate with colleagues across different regions and cultures, allowing me to develop strong interpersonal and communication skills in a global, multicultural environment. Additionally, I am skilled in using Microsoft Office tools and other software to produce high-quality documents under tight deadlines.I take pride in my attention to detail, problem-solving abilities, and creative approach to document production. These skills enable me to thrive in a fast-paced, highly regulated industry where precision and quality are paramount.I am passionate about contributing to the advancement of clinical research by ensuring that regulatory documents are meticulously prepared and that they meet the rigorous standards required by global health authorities.
EDUCATION
Imperial College London
Master of Philosophy - MPhil, Clinical medicine
Imperial College London
Master of Science - MS, Human/Medical Genetics
ABOUT ARUNON SIVANANTHAN
I am a committed medical and regulatory writer with comprehensive experience in life sciences, specialising in gastroenterology, genetics, and inflammatory diseases. I have worked in a variety of therapeutic areas, including respiratory medicine, infectious diseases, and immunology. My hands-on research background, combined with a deep understanding of scientific communication, equips me to present complex scientific data in an accessible and precise manner. Over my career, I have contributed to a wide range of clinical study reports, safety narratives, development safety update reports, and informed consent forms. I am adept at adhering to regulatory guidelines, such as ICH and GCP, ensuring that all documentation meets industry standards and remains compliant with regulatory requirements.Most recently, as a Junior Medical Writer at Caidya, I supported clinical and regulatory writing efforts across several therapeutic areas. I played a pivotal role in the production of key documents for clinical studies, working in oncology, immunology, and respiratory diseases. My ability to effectively collaborate with cross-functional teams and deliver results within tight deadlines has been essential to my success.Prior to my role as a medical writer, I spent several years in academic research. I hold an MSc in Human Molecular Genetics and an MPhil in Clinical Medicine from Imperial College London, which have provided me with advanced skills in experimental design, data generation, and computational analysis. During my research tenure at the Centre for Paediatric Gastroenterology at Royal Free Hospital, I was involved in innovative studies investigating the role of bacterial effectors in pathogenesis, using cutting-edge in vitro organ culture and microscopy techniques. This research was published in well-regarded, peer-reviewed journals.I am driven by a passion for using my research background to contribute to the development of medical therapies through effective writing. My goal is to continue growing as a medical writer, producing scientifically rigorous, regulatory-compliant documents that support drug development and improve patient outcomes. I remain dedicated to ongoing learning and have completed numerous professional development courses in areas such as pharmacokinetics, clinical study reporting, and editing and proofreading.Feel free to connect with me if you\'d like to collaborate on medical writing, regulatory documentation, or clinical research projects.
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