Áine has a broad scientific background, with post-graduate experience in basic research and a PhD in neuroscience. Following a career in academia, which included an adjunct professor role at the New York University, Áine joined NAMSA’s Syntactx in 2017 to apply her research and problem-solving skills in medical writing. She currently manages regulatory and clinical writing teams.

CORE COMPETENCIES

• Managing project timelines and resourcing for regulatory and medical writing projects
• Providing mentorship and leadership to the regulatory and medical writing team
• Developing Clinical Evaluation Plans and Reports (MEDDEV 2.7.1/rev. 4 and EU MDR)
• Performing systematic literature reviews and analysis of data extracted from the literature for regulatory submissions
• Preparing manuscripts, protocols, study reports and other deliverables in conjunction with clinical teams
• Working with the internal regulatory strategy team and Sponsors on submissions to the U.S. Food and Drug Administration (FDA)
• Assisting Sponsors with responses to queries from regulatory bodies

RECENT PROJECTS

• Worked with several Sponsors on transitioning Clinical Evaluations in order to meet MDR
• Successfully assisted Sponsors with responses to Notified Bodies
• Drafted a clinical manuscript that has been recently published in a peer-reviewed journal