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Office: Office of New Animal Drug Evaluation
Division: Division of Therapeutic Drugs for Food Animals
In my current position, I review therapeutic drugs for food animals for safety and effectiveness prior to their approval and release on the market. More specifically I work with dewormers and physiologic drugs such as non-steroidal anti-inflammatory drugs (NSAIDs) and reproductive drugs. I look at studies that drug companies have conducted in order to prove their products are safe and effective. I review blood work, necropsies, and study procedures. I work with drug companies to develop study protocols and to help them understand our regulatory framework. Although entirely different from my position as a veterinarian within a practice, I love this job.
This position allows me to combine the veterinary knowledge I gained in school with the practical experience I gained in the field and collaborate with not only my federal colleagues, but also scientific experts in various fields. Scientific discussions revolving around the methodology of a new diagnostic test or the most recent paper on an infectious livestock disease are frequent occurrences within my office that have challenged me to apply my knowledge and experience to the task at hand.
Outside of my regulatory review duties, I have been fortunate in this position to take part in spearheading a new initiative focused on educating the public about antiparasitic resistance in grazing livestock. This opportunity has truly been my pride and joy on which to work, granting me leadership and public speaking skills that I would not have been able to accomplish otherwise.
The thought of contributing to something as part of a far bigger whole is exciting to me and one major reason I was originally drawn to CVM. The longer I am here, the more opportunities to professionally excel reveal themselves, which I believe is a great strength of the Center’s. The perception of a public servant in the face of today’s growing agricultural challenges is humbling and inspirational to me and ultimately why my tenure here at CVM has been so enriching and continues to grow.
Office: Office of New Animal Drug Evaluation
Division: Division of Scientific Support
Education: Ph.D., Statistics
About 10 years ago, I joined CVM as a statistical reviewer in the Division of Scientific Support. I collaborated with veterinary reviewers and other scientists to evaluate animal drug approval applications. I worked with veterinary reviewers to evaluate whether the design, observations, and statistical analysis of a study proposed by a drug sponsor will likely generate quality data appropriate to the drug claim being tested. Additionally, when a sponsor submits the report from a study conducted to support effectiveness or safety, I provide the statistical expertise to evaluate the quality of the data generated from the study, and whether the data supports the approval. Today, using the knowledge and experience I gained, I mentor new reviewers and help develop a working environment that fosters collaboration among scientists from different disciplines in order to develop drug review processes that are efficient, adhere to scientific principles, and are responsive to the needs of the American public.
CVM is a great place to work for me for several reasons.
First, I like applying statistics to real world problems. A CVM statistician works daily on issues that directly impact the safety and effectiveness of drugs on the animals that need them and the safety of humans that may consume dairy, meat, and other animal products.
Second, the diversity, dedication, and creativity of the professionals working for animal drug regulation make CVM a challenging and fulfilling place to practice my profession. On any given day, I can be in discussions with veterinary medical officers, management specialists, policy advisors, molecular biologists, or even fellow statisticians.
Third, CVM is an organization that nurtures creativity and innovation. Each person has the opportunity to participate in improving review science, the center’s business processes, and office policy; and contributions are recognized and rewarded. Management creates and maintains a work environment that fosters work-life balance through flexible working hours, teleworking, and other office policies that allow employees flexibility to schedule work and personal commitments around each other.
Office: Office of New Animal Drug Evaluation
Division: Division of Human Food Safety
Team: Residue Chemistry Team
Education: Ph.D., Endocrinology and Animal Biosciences
I began at CVM immediately after obtaining my doctorate degree in Endocrinology and Animal Biosciences. I knew that I did not want a position in academia. However, a government position had never crossed my mind until I received an email from a member of my graduate committee passing along a job posting at CVM. Although I was not offered that initial position, my CV was passed along and here I am – a biologist on the Residue Chemistry Team in the Division of Human Food Safety. As a member of the Residue Chemistry Team, I:
- evaluate drug residues in the edible products of treated food animals and recommend tolerances and withdrawal periods and/or milk discard times;
- discuss residue chemistry data requirements with a diverse customer base;
- facilitate U.S.A. approval of safe and effective new animal drug products for use in food-producing animals; and
- interface with scientific regulatory counterparts to ensure continuous improvement in worldwide human food safety practices.
Although review work is the main part of my job, I have been involved in various projects updating federal regulations and exploring the feasibility of pursuing other statutory revisions, consistent with the Agency’s mission to protect and promote the public health. Such projects have helped me to expand my statutory writing skills and provide me with a broader network of colleagues within CVM. In addition, I am an invited speaker at the Office of Regulatory Affairs (ORA) tissue residue and nonclinical Good Laboratory Practices (GLP) training courses for FDA inspectors, where I am responsible for presenting an overview of human food safety information. These courses allow me to get back to my roots of teaching and interact with the inspectors in the field who have a different perspective of the drug approval process than those of us working at the Center level.
CVM has many attractive qualities and strengths that have made it easy for me to stay. One of the main attractants was the work-life balance. Having just finished a PhD program, spending 16+ hours in the lab a day, being able to have a flexible schedule and work from home was a definite plus. As an added bonus, the ability to interact with other scientists, veterinarians, policymakers, members of industry, etc., on a daily basis has helped to keep me abreast of the new science and policy. I am using my graduate training in a way that I never thought possible; combining my joy of science and critical thinking with my passion for writing. One would think that, as a reviewer, the job would become monotonous; however, that is not the case. No two submissions are alike and each presents their own challenges; not to mention the additional side projects with which we are tasked.
Office: Office of Management/Immediate Office
Education: B.A., Business Administration
I came to CVM after 15 years at the National Institutes of Health where I was an Administrative Officer (AO). As an MO in the Immediate Office (IO) of the Office of Management I support OM administratively. This consists of preparing and tracking the OM Payroll and Operating Budgets, approving all procurement and travel orders, acting as a Card Approving Official (CAO) for all of OM’s purchase card holders, preparing Human Resource (HR) packages, acting as a timekeeper, acting as a COR for OM’s contracts, and other administrative duties. While I am part of OM/IO I also support the Office of Minor Use Minor Species (OMUMS) as their MO. As an MO with my hands in so many different pots I am in a unique position to recognize areas we can make improvements to processes which is one of the things I enjoy most about my job.
One of my favorite projects I have been part of is being a part of the group that developed the Center’s new Core Values. I volunteered to be part of the group figuring as a newer employee it would be a great opportunity to network, learn more about the culture here at CVM, and put a little bit of my mark on the Center. I enjoyed being a part of this group and the project itself so much more than I even expected. I got to use a grassroots effort and work with employees and leadership across the Center I would not normally have the opportunity to interact with. I got to see firsthand what employees at all levels of the Center felt was most important to the Center and use some of my creativity (the little I have) to mold and meld the feedback to become Core Values everyone truly can believe in.
CVM has many strengths but the one that still astonishes me the most is just how much effort and real action is put into the culture here. There is a real effort to ensure the work environment is one of collaboration, empowerment of everyone (regardless of position), balance (work/life), learning, progression forward in all areas, and a culture flexible and reflective enough to continue to sustain it.
Another strength of CVM is their training program. The Center offers training to all employees in a variety of areas including technical and soft skills. Employees are encouraged to take the training and provided opportunities to use what is learned every day.
I try to demonstrate each of the Core Values as often as possible. The Core Value We Serve is one that I demonstrate on a daily basis. It is part of my position every day to serve my “customers” inside OM and OMUMS but I also am given the opportunity to serve others in CVM quite often. I do this by volunteering for various CVM committees and programs, providing back-up for other MOs when they are out of the office, acting as a liaison between the other MOs and the various OM staffs, and being willing to assist anywhere I am needed.
Office: Office of Management
Team: Program Resource and Management Staff (PRMS)
Education: B.S., Finance
I joined CVM in 2010 after working as a Purchasing and Shipping Manager in the private sector for 3+ years. My initial goal in coming to the Government side was to become a contract specialist. After applying to 50+ positions in the span of a few months, a friend shared a job announcement at CVM that involved supporting acquisitions. I had never heard of CVM, but in reviewing the FDA website, I knew immediately that I could support its mission and be proud to be part of the organization. At first my role was to support Activity Time Reporting (ATR) and the Purchase Card. While I enjoyed supporting both programs and working with wonderful people along the way, my interests from the start was in acquisitions. My role slowly transitioned to assisting Michelle Fuller, CVM’s Acquisition Liaison, in reviewing acquisition packages(documents) and ultimately assisting in the establishment of the PRMS Acquisition Team. In my latest role I support Office of Research (OR) and CVM’s IT staff as their office Acquisition Liaison. I also manage the CVM Central budget.
In my role as Acquisition Liaison, I assist in developing the acquisition packages (documents) required to set up new contracts and assist in seeing them through to award, assist in post-award issues that may arise, and assist in invoice receiving and closeout. What I enjoy with acquisitions is the feeling of accomplishment and the ability to serve my “customers.” In addition, there is truly never a dull moment. Each contract action is unique, each may have their challenges, and since many of these contracts are one year in length, at any given time I can be supporting pre-award or post-award actions on ~200 contracts. I never quite know what challenges or opportunities I may face on a daily basis and it’s this experience that keeps things interesting.
In my role in managing CVM Central Budget, I assist in planning the annual budget and executing the approved budget which includes approving orders, planning and tracking spending to three fund types, and reconciling the budget. For those that are not familiar, the CVM Central Budget covers CVM-wide requirements such as Center IT requirements, PC Refresh, Safety, TDLC, Awards Ceremony, Moving Services, Fleet, etc. I enjoy this work because I have the opportunity to see things from a budget perspective. I also have the opportunity to work with many great people who help support the Central budget.
Besides the mission, what I like most about CVM is our relatively small size and the opportunities that this presents to us. The opportunities being the ability to volunteer for cross-cutting work groups or to otherwise assist with an initiative that can benefit multiple offices or the whole Center. Other opportunities include the mentorship programs and the variety of learning experiences that TDLC provides. It’s these experiences that allow CVM employees to stretch and grow. I am not sure you would have the same opportunities at a large center. Lastly, I enjoy all the people that make CVM a high performing organization. The talent, the shared mission focus, and the (unspoken) “leave your title at the door” culture make CVM what it is; a great place to work.