My name is Greg Morehouse.
I have been working as a medical or scientific communicator for more than a decade. I’ve spent the last 4 years as a clinical and regulatory medical writer with broad experience across in vitro diagnostics and companion diagnostics for oncology and infectious disease applications. Prior to that, I spent 4 years as a researcher (with 3 significant publications and a MS thesis to show for it), and 4 years as a scientific communicator (through the lens of secondary and post-secondary education). I have direct working familiarity with US FDA, EU/EC, and Health Canada regulations for drugs, IVDs, and medical devices, as well as regulatory and clinical guidance documents from ICH, CDER, CBER, CDRH, EU MDCG, EMA, Health Canada, CLSI, and others. From the regulatory side, I am familiar with the eCTD for drugs and the 510(k) and PMA pathways for devices. From the clinical side, I have experience with INDs and IDEs, as well as clinical protocols and clinical study reports. I also have extensive expertise in writing and reviewing product labeling at all stages, especially package inserts, clinical and investigator brochures, and instructions for use.
In my work, my sole focus is producing documents of superior quality while delivering on time. Because of this, I thrive in fast-paced, matrixed environments and cross-functional teams, where I facilitate the writing, editing, and submission of clear, compliant, and strategic documents for regulatory and clinical submissions to US, European, Canadian, and other international regulators, notified bodies, and conformity assessment bodies. I take an critical and audience-centered approach to document creation, and my mastery of project management, gap analysis, and change control processes ensures that the document produced is clear, complete, and quickly done.
Within my first 2 years as a medical writer, I had already demonstrated mastery sufficient to propel me into leadership of a multi-year project across an entire division’s portfolio, including onboarding, developing, and managing a team of 2-5 contract medical writers. When I saw that our training materials were insufficient to quickly onboard so many people, I built new ones. Where our processes were insufficient, I facilitated the revision of existing processes, or I created new ones. Of the contractors that worked for me, 3 are now full-time medical writers, and the joy of training and developing them as medical writing professionals is the greatest reward I could receive. I am more than willing to share and discuss my knowledge with others, as evidenced by my presentations at regulatory and medical writing conferences, including RAPS Convergence 2020.
In terms of functional area expertise, I have deep knowledge of medicinal chemistry, biochemistry, molecular biology, and pharmacology, especially in the following subfields:
- Infectious Diseases
- Oncology
- Immunology
- Psychiatric Medicine
While these areas are where my previous projects have taken me, I am ALWAYS interested in diving deep into a new area to support the needs of both professionals and clients in these areas.
Please feel free to contact me for project opportunities through this website.
gregmorehouse.com 