Julie Kirkwood

Regulatory Senior Medical Writer

Rochester, NY

Senior Medical Writer with expertise in preparing regulatory documents for clinical trials (protocols, IBs, IND). Former science/medical journalist.

Julie Kirkwood

Regulatory Senior Medical Writer

Rochester, NY

Senior Medical Writer with expertise in preparing regulatory documents for clinical trials (protocols, IBs, IND). Former science/medical journalist.

Solving Medical Mysteries
A child came to Vanderbilt University Medical Center in Nashville, Tennessee earlier this year with an illness that resembled progeria, a rare genetic disorder in which children manifest symptoms of old age. Her symptoms were more severe, though, and the test for a mutation in the LMNA gene, which would confirm a progeria diagnosis, came back negative.
Clinical Laboratory News
Preventing the Next Flint
Often when a child is poisoned by lead, there are no symptoms. Only a blood lead level test alerts parents to the danger. Otherwise, the child is at risk for irreversible learning disabilities and developmental delays. “By the time they see me when they’re school age, the lead is gone and has already done its damage,” said Jennifer Lowry, MD, a pediatrician at Children’s Mercy Hospital in Kansas City, Missouri, and director of the Mid-America Pediatric Environmental Health Specialty Unit.
Clinical Laboratory News
From Standalone to Enterprise-Wide
Two years ago, the University of Arkansas for Medical Sciences in Little Rock took what chief medical information officer Thomas Powell, MD, calls the “big bang” approach to changing software throughout its hospital and clinics. Every department simultaneously converted to Epic, including the laboratory, which switched to Epic Beaker.
Clinical Laboratory News
A special dentist for people who need special care
When dentist Wayne Lipschitz heads home after a Friday in the operating room, he’s exhausted. This is his one day of the week to clean and repair the teeth of people whose developmental disabilities are so severe that they could not be treated in a regular dental office.
Rochester Magazine
The Next Step for Molecular Point-of-Care Testing
The year 2015 may well be remembered as the the time when molecular diagnostics began to expand beyond the laboratory. In January, the Food and Drug Administration (FDA) granted its first CLIA waiver to a nucleic acid-based test, the Alere i Influenza A&B. A few months later, Roche received a CLIA waiver for the cobas Liat System and Strep A.
Clinical Laboratory News
Bridging the Health Disparities Gap
How laboratories can improve care for vulnerable populations.
Clinical Laboratory News
Laboratorians Take on Legal Marijuana Testing Challenges
In the days when marijuana was illegal throughout the United States, testing was simple. If cannabinoid metabolites showed up in urine, a person clearly had broken the law. Now that 23 states and the District of Columbia have laws legalizing marijuana in some form, testing has gotten trickier. Police and employers need to know not just whether someone used marijuana, but if the individual did so recently and in amounts enough to cause impairment.
Clinical Laboratory News
Health care systems leverage data to improve care
Earlier this year, receptionists at the University of Rochester Medical Center’s orthopedics practices started handing patients iPads at check-in. The patients spend two or three minutes in the waiting room answering questions about their general health. Are they getting around the house without too much trouble?
Rochester Business Journal
Leader invents a better way
Jude Sauer M.D. was confident his company’s new surgical device would work as he stood in the operating room awaiting its first surgical case. An earlier generation of the suturing technology already had been used successfully in dozens of patients, and this next generation had been subjected to thousands of tests.
Rochester Business Journal
Leading a historic institution: Eli Eliav became director of the Eastman Institute for Oral Health in 2013
Driving home from Niagara Falls nearly 20 years ago, Eli Eliav DMD passed Rochester on the Thruway. He remembers turning to his wife and saying, “You know, here in Rochester is one of the best places in dentistry in the world.”. He was just beginning his career in dentistry then. He had brought his wife and two young children from Israel to the United States for two years so he could do a research fellowship at the National Institutes of Health in Maryland.
Rochester Business Journal
Mouth guards: why they're needed, how to choose
a little piece of plastic that fits over your teeth — might seem like a simple thing, but think again. It could cost as little as a dollar, or more than $500. Debates fill the pages of medical journals about which teeth they should cover, whether they work at all, how well and for whom. And a mouth guard that’s effective for one use, such as hockey practice, may not work for another, such as relieving jaw pain.
Rochester Democrat and Chronicle
Knitting, crocheting projects help addicts find peace during recovery
Women in drug treatment pick up needle work.
The Salem News
Health features Addiction

About

Julie Kirkwood

medical writing

clinical trials

regulatory documents

lead writer

regulatory submissions

problem solving

cross-functional teams

I am an award-winning medical writer with more than 17 years of medical writing experience.

Since 2017, I have worked in the pharmaceutical and biotechnology industry preparing documents for regulatory submission in support of clinical trials (e.g., protocols, investigator's brochures, data summaries, cardiac safety reports, statistical analysis plans). I am currently a Senior Medical Writer at CRISPR Therapeutics, working on gene-edited cell therapies in oncology.

While the documents I write now are confidential, shown here are public examples of bylined medical articles that I wrote for professional and general audiences earlier in my career. Prior to becoming a regulatory medical writer, I ran a successful medical writing consulting business, writing white papers, online content, marketing materials, and bylined magazine articles for science, medicine, and business publications. Prior to that, I spent the first decade of my career as a staff writer for daily newspapers, specializing in health and science news.