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Áine Mary Duffy, BSc (Hons), PhD

Manager, Regulatory & Medical Writing Services

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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.