Raquel Billiones has a PhD in Biology and more than 25 years combined experience in scientific and clinical research. She has been a medical writer for more than 13 years, with core competencies in writing clinical trial and regulatory documents for pharmaceuticals and medical devices. Her medical device experience includes writing clinical investigation plans and reports and clinical evaluation plans and reports for CE Class II and Class III medical devices. Her experience also includes transparency, disclosure and patient data protection in clinical trial data reporting. Previously, she served as Head of Medical Writing at Takeda Vaccines. She also worked for a mid-sized global CRO where she established and led a small team of writers and support staff located in the US, Europe, and Asia. Raquel is an active member of EMWA, serving in various roles, including as Executive Committee member (2015-2017), associate editor of MEW (2010-present), internship advocate, workshop leader, and member of the Medical Device Special Interest Group (MD SIG).