The document provides biographical and professional information about Megan (Cuomo) Walter, PharmD, including her education, professional experience working for the FDA, Janssen Scientific Affairs, and Purdue University College of Pharmacy, teaching experience, research and publications, professional projects, and leadership roles. She currently works as a Pharmacist for the FDA Division of Drug Information where she answers regulatory drug information questions and precepts students and fellows.
The document provides biographical and professional information about Megan (Cuomo) Walter, PharmD, including her education, professional experience working for the FDA, Janssen Scientific Affairs, and Purdue University College of Pharmacy, teaching experience, research and publications, professional projects, and leadership roles. She currently works as a Pharmacist for the FDA Division of Drug Information where she answers regulatory drug information questions and precepts students and fellows.
The document provides biographical and professional information about Megan (Cuomo) Walter, PharmD, including her education, professional experience working for the FDA, Janssen Scientific Affairs, and Purdue University College of Pharmacy, teaching experience, research and publications, professional projects, and leadership roles. She currently works as a Pharmacist for the FDA Division of Drug Information where she answers regulatory drug information questions and precepts students and fellows.
The document provides biographical and professional information about Megan (Cuomo) Walter, PharmD, including her education, professional experience working for the FDA, Janssen Scientific Affairs, and Purdue University College of Pharmacy, teaching experience, research and publications, professional projects, and leadership roles. She currently works as a Pharmacist for the FDA Division of Drug Information where she answers regulatory drug information questions and precepts students and fellows.
5400 10th St N megan.cuomo@fda.hhs.gov or Arlington, VA 22205 megcuo2018@gmail.com 919-624-3649
Education and Post-Graduate Training:
Regulatory Pharmaceutical Fellow in Drug Information June 2020
Purdue University College of Pharmacy | Janssen Scientific Affairs, LLC | Food and Drug Administration
Doctor of Pharmacy May 2018
Bachelor of Science in Pharmaceutical Sciences May 2017 University of North Carolina Eshelman School of Pharmacy
Professional Experience:
Food and Drug Administration, Division of Drug Information (Silver Spring, July 2020 - Present MD) Pharmacist Answering regulatory drug information and MedWatch phone calls and emails from consumers, health care providers, and industry professionals Participating in the Expanded Access Coordinating Committee Participating in the Division of Drug Information’s Facebook response team and GADIS: Global Alliance of Drug Information Specialists response team Precepting students on rotation in the Division Precepting Regulatory Pharmaceutical Fellows in Drug Information Leading the Division and training new hires on time reporting Team Leader: Kara Burke, PharmD
Food and Drug Administration, Division of Drug Information (Silver Spring, January 2020 – June 2020 Maryland) Drug Information Fellow Answered regulatory drug information and MedWatch phone calls from consumers, health care providers, and industry professionals Assisted with the Expanded Access program Participated in the Division of Drug Information’s Facebook response team and GADIS: Global Alliance of Drug Information Specialists response team Precepted students on rotation in the Division Managed updates of standard responses for common questions Preceptor: CDR Lindsay Wagner, PharmD, BCPS
Janssen Scientific Affairs, LLC (Titusville, New Jersey) January 2019 – December 2019 Medical Information Fellow, Cardiovascular & Metabolism Reviewed professional, payer, sales training, and consumer materials for scientific accuracy and fair balance
Megan Walter, PharmD
Page 1 of 5 Updated and authored scientific responses, including leading these updates for a new indication launch Collaborated with a cross-functional team to determine needs and compliant interactions with electronic health records and clinical pathway developers Staffed medical information booths at medical conferences to answer provider questions Trained medical information staff on label updates and review of new literature Managed a vendor completing medical writing projects for the team Preceptors: Samina Ali, PharmD; Payal Desai, PharmD
Purdue University College of Pharmacy/Indiana University Methodist Hospital July 2018 – December 2018 (Indianapolis, Indiana) Drug Information Fellow Responded to drug information questions from health care professionals in the Indiana University hospital system Assisted with precepting students and residents on clinical rotation at the Drug Information Center Completed a medication use evaluation Updated a therapeutic class review for a health system Pharmacy and Therapeutics Committee Completed a gap analysis of the hospital system pharmacy resource site Initiated a pharmacy education research project Completed activities required for Indiana Pharmacy Teaching Certificate Preceptor: Amy Sheehan, PharmD
Realo Discount Drugs (Clayton, North Carolina) September 2017 – April 2018 Pharmacy Intern Manager: Chris Wright, PharmD
ZeroChaos contracted to ViiV HealthCare (Durham, North Carolina) December 2016 – April 2017 Clinical Pharmacology Intern Managers: Katy Moore, PharmD; Parul Patel, PharmD
ZeroChaos contracted to GlaxoSmithKline (Durham, North Carolina) May 2016 – November 2016 Safety Evaluation and Risk Management Intern Manager: Amy Timberlake, PharmD
CVS Health (Morrisville, North Carolina) January 2015 – November 2016
Pharmacy Intern Manager: Lisa Stephenson, PharmD
Teaching Experience:
Food and Drug Administration (Silver Spring, Maryland) July 2021 – Present Serve as a preceptor for Regulatory Pharmaceutical Fellows in Drug Information on their rotation in the Center for Drug Evaluation and Research, Division of Drug Information Serve as teaching mentor for fellows co-precepting pharmacy students
Food and Drug Administration (Silver Spring, Maryland) May 2021 – Present Megan Walter, PharmD Page 2 of 5 Serve as a preceptor for fourth-year pharmacy students on advanced pharmacy practice experience elective rotation in the Center for Drug Evaluation and Research, Division of Drug Information
Food and Drug Administration (Silver Spring, Maryland) February 2020 – March 2020, January 2021 Served as a co-preceptor for fourth-year pharmacy students on advanced pharmacy practice experience elective rotation in the Center for Drug Evaluation and Research, Division of Drug Information Teaching Mentors: CDR Lindsay Wagner, PharmD, BCPS; Kara Burke, PharmD
Purdue University College of Pharmacy (Indianapolis/West Lafayette, Indiana) July 2018 – November 2018 Course Instructor – PHRM 84800: Principles of Drug Information and Literature Evaluation Development and grading of course assignments Development of quiz and final exam questions Led two class sessions (4 hours) Assisted during all regular office hours (3 hours per week) Teaching Mentor: Amy Sheehan, PharmD
Purdue University College of Pharmacy (Indianapolis, Indiana) September, November 2018
Led two interprofessional education sessions for pharmacy, medical, dental, nursing, and physical therapy students (5 hours) Goal: for students to better understand each other’s professional roles and how interprofessional teams can work together to improve patient care Teaching Mentor: Amy Sheehan, PharmD
Purdue University College of Pharmacy (West Lafayette, Indiana) October 2018
Assisted in facilitating diabetes point-of-care lab for second-year pharmacy students (3 hours) Teaching Mentor: Amy Sheehan, PharmD
Purdue University College of Pharmacy (West Lafayette, Indiana) October 2018
Facilitated a journal club critique for third-year pharmacy students during PHRM 860: Professional Program Lab (1 hour) Teaching Mentor: Amy Sheehan, PharmD
Purdue University College of Pharmacy/Indiana University Methodist Hospital September - October 2018 (Indianapolis, Indiana) Served as the primary preceptor for a fourth-year pharmacy student on a four- week academia rotation Teaching Mentor: Amy Sheehan, PharmD
For full teaching portfolio, please access the following link: Completed May 2019 https://mccuomo.weebly.com/
Research & Publications:
Cuomo MC, Sheehan AH, Jordan JK. Solriamfetol for the management of excessive daytime sleepiness. J Pharm Pract. Published online April 22, 2021. doi: 10.1177/08971900211009080. Megan Walter, PharmD Page 3 of 5 Using interactive, online, evidence-based practice (EBP) teaching modules for July 2018 – December 2018 interprofessional education (IPE) Conducted a needs assessment around EBP education with nursing and pharmacy students Preceptor: Amy Sheehan, PharmD
Pharmacy adjusted single dose pre-op gentamicin and the effect on post-op February 2018 renal function Poster presented at the 13th Annual Duke Health Quality and Safety Conference (Durham, North Carolina) Preceptor: Allison Armagan, PharmD
Vaccination rates among school employees: a review of workplace annual September 2017 influenza vaccination clinics in a rural North Carolina county Poster presented at the American Society of Health-System Pharmacists Midyear Clinical Meeting 2017 (Orlando, Florida) Preceptor: Christy Holland, PharmD
Professional Projects:
Serving as a peer reviewer for Annals of Pharmacotherapy and Journal of October 2018 – Present Pharmacy Practice Authoring a book chapter for Drug Injury: Fifth Edition June 2020 – March 2021 Assisted in review of submitted sessions for the American Society of Health- February 2020 System Pharmacists Midyear Clinical Meeting 2020 Assisted with coordination of Johnson & Johnson’s 3rd Annual PharmD Summit August 2019 Developed and published an Indiana Teaching Certificate Program (IPTeC) December 2018 newsletter article
Leadership:
Student Fellowship Workshop Leader October 2019
Purdue University College of Pharmacy Assisted with a half day workshop of third- and fourth-year pharmacy students, answering questions regarding fellowship applications and selection, as well as completing mock interviews
Purdue Industry Pharmacist Organization (IPhO) Industry Pharmacists September 2019 – May 2020 Advisory Council Member Purdue University College of Pharmacy Mentor pharmacy students considering careers in pharmaceutical industry
Industry Pharmacists Organization (IPhO) Mentor September 2018 – April 2021
Eshelman School of Pharmacy Mentoring pharmacy students considering careers in pharmaceutical industry and post-graduate fellowships Conducted mock interviews, provided writing tips, and provided information on interviewing for fellowships as a part of a fellowship preparation series
Megan Walter, PharmD
Page 4 of 5 Presentations:
Government Response to COVID-19 April 2020
Purdue University College of Pharmacy Presented a 0.25 hour continuing education course as a part of an hour series called “2020 COVID-19” virtually: https://ce.pharmacy.purdue.edu/courses/
Xarelto Use in Patients with Nonvalvular Atrial Fibrillation and Obesity September 2019 Janssen Scientific Affairs, LLC Presented to cardiovascular therapeutic area medical information staff at Janssen to review new evidence
Antiphospholipid Syndrome and Xarelto Label Change August 2019
Janssen Scientific Affairs, LLC Presented to cardiovascular therapeutic area medical information staff at Janssen in anticipation of US Prescribing Information update; also covered disease state background
Literature Search Strategies and Resources July 2018
Purdue University College of Pharmacy Presented a refresher on literature searching techniques to Purdue University PGY1 community pharmacy residents in preparation for initiation of research projects
Professional Organizations:
American Society of Health-System Pharmacists September 2014 – December 2021
American Association of Colleges of Pharmacy October 2018 – December 2019 American Pharmacists Association September 2014 – December 2018 North Carolina Association of Pharmacists September 2014 – October 2018
Licensures and Certifications:
Indiana Pharmacy Teaching Certificate (IPTeC) Program June 2019
Registered Pharmacist, State of North Carolina June 2018 – Present APhA Pharmacy-Based Immunization Delivery March 2015 – Present Basic Life Support Provider October 2014 – Present
Additional Skills
iConnect use in medical information (also known as Salesforce)
EndNote use for creating citations for scientific responses Veeva Vault for promotional review and scientific response management
