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May 2017

Amanda Krzywinski, MPS


Amanda obtained a Bachelor’s in Biology and Chemistry at Meredith College and worked at Sensors Safety Products Inc. for two years in the analytical chemistry side before going to graduate school. She completed her Master’s in Professional Science in Toxicology at UNC in 2015. Amanda is currently a regulatory writer at Synchrogenix in Raleigh, NC.


What is your story? How did you get interested in toxicology?

I had a major in chemistry for the first 2 years of undergrad. By senior year, I realized that I was more interested in biology and decided to also get a degree in Biology. This landed me a job in a chemistry lab that was doing testing on exposure levels to hazardous chemical vapors, such as formaldehyde, benzene, and nitrous oxide. I analyzed the chemicals collected by sensors worn by people (e.g. industrial hygenists, pathologists, forensic toxicologists, in hospitals) and sent them back data about their exposure levels. I liked working there, but for me it wasn’t enough to know what they were being exposed to; I wanted to know why this chemical was harmful. That information wasn’t emphasized at that job, and I had to find it out on my own. I was really interested in the biochemistry of these chemical exposures and wanted to learn more so I looked into UNC’s PhD program in Toxicology. After talking with the advisor there, she said the Master’s program seemed to be a better fit for me and my career goals as it was shorter and included business courses. I strongly agreed, and quickly enrolled in the program.

What did you do after graduating?

After graduating from the Professional Science Master’s program, I started looking at a lot of jobs. I didn’t really know what I wanted to do specifically but I knew I wanted something in the pharmaceutical industry. I had completed an internship at a pharmaceutical company, learning about nonclinical toxicology and drug safety, and I knew that I wanted to play a part in making pharmaceutical products safer for patients. I found Synchrogenix which is a company that does regulatory writing. It sounds boring from the outside but as I dove more into in, it became more and more interesting.

Essentially, we are hired by pharma companies to write their regulatory documents. These include anything for submissions to the FDA, clinical study protocols, and also documents on the non-clinical side. I get to work with many different pharma companies, for all different kinds of drugs, and be some of the first eyes on what kinds of new drugs they are working on.

Can you describe what you do? What does it look like day to day?

I work on various projects from different companies. A project can last from 8 weeks to 6 months, and sometimes even longer than that. I currently write a lot of clinical study protocols and manage the communications from our company to the client, handle emails, set up meetings, etc.

When I go to work every day, I think about what I need to do on this document today for my client, when is this draft due, how many hours do I need to finish it. The structure of the process changes depending on the project and the needs of the client. Sometimes they have an idea of how the protocol should look already, which makes my job much easier. Sometimes I get a company who has never written a protocol before and they ask me to take the lead on it. Other times they want me to write the background information for the project, so I get to do some research on the drug and indication before writing. Overall, I manage the client’s wants/needs for their project while ensuring that their document remains in compliance with regulatory guidelines.


What is your favorite/least favorite part about what you do?

I love seeing the finished product. After so many weeks of working on what started out as an ugly document, it is so satisfying to see it transformed to a beautiful finished product. I like being able to be apart of new drugs on the market. It is so cool to know that you had a hand in something like curing cancer, just by helping with the regulatory writing for an oncology drug. Your name is never on any of these documents but you know that you helped get this drug approved, and that’s pretty special.

My least favorite part is the stress that comes with the timelines. Pharma companies tend to be on a tight timeline; missing a day can lead to million-dollar losses. So there is a lot of pressure to meet those deadlines. I have had to work some late nights, some weekends, but they are rare if you plan well enough and get study teams to work with you.

What were the most valuable skills you gained from your time at UNC?

I learned how to manage my time to effectively in order to complete all the tasks I had to do, like writing a hundred-page risk assessment for Jim Swenberg in Advanced Toxicology, going to many classes and seminars, and finding an internship all at the same time. The Master’s program provided a lot of useful courses like Project Management and Professional Writing and brought in valuable guest speakers in the PSM seminars where I learned about their career and their transition from school to work. There is a really great support system for students at UNC that are like, let me help you!, and I really appreciated that during my time there.

Any advice to current students/postdocs?

Internships! I think that was the biggest help in getting me my current job. I worked at United Therapeutics for a summer and started looking at many of their documents, like Nonclinical Study Protocols, Nonclinical Reports, Investigator’s Brochures, Drug Safety Update Reports, and Periodic Benefit Risk Evaluation Reports, just to name a few. It wasn’t necessarily what I was planning on doing, but it was that experience that got me through the door at the job that I have now. You never know where an internship will take you with the experience that you get and the contacts that you make.


What do you enjoy doing in your free time?

I really just love to spend quality time with my friends. It’s hard to do when you all move into a 9-5 job but it’s such an important part of life!