About FDA

Regulatory Pharmaceutical Fellowship

Regulatory Pharmaceutical Fellowship
 

2016 – 2018 Positions Filled: Drug Information Track and Medication Safety Track

Food and Drug Administration/Industry/Academia Fellowship 2016-2018
Jointly Sponsored By: Food and Drug Administration (FDA), Purdue University, Janssen Scientific Affairs, LLC, and Eli Lilly and Company

Introduction

The purpose of the Regulatory Pharmaceutical Fellowship is to train selected candidates in one of three tracks focused on the medical and regulatory aspects of drug information dissemination, drug advertising and promotion, or medication safety. The program serves to maintain and enhance a scientific link among the Food and Drug Administration (FDA), academia, and the pharmaceutical industry. The program also provides an opportunity for the fellow to develop an understanding of the processes of the FDA and the pharmaceutical industry in the delivery of drug information, the regulatory oversight of prescription drug marketing practices, and the assessment and enhancement of medication safety. The fellowship gives participants the unique opportunity to experience careers in the areas of government, academia and industry, thus, qualifying graduates to pursue career opportunities in each respective area.

The fellowship is a two-year program consisting of rotations with FDA's Center for Drug Evaluation and Research, Purdue University College of Pharmacy, and Janssen Scientific Affairs, LLC or Eli Lilly and Company.

The program filled two positions for 2016-2018: one in Drug Information and one in Medication Safety.

The program tentatively plans to recruit for the following positions in late fall of 2016 for the 2017 – 2019 cycle: Drug Information and Drug Advertising and Promotion.

Fellowship Schedule

Drug Information 2016 – 2018 Fellow: Sandra Bai, Butler University College of Pharmacy & Health Sciences, Class of 2016

July 2016 – December 2016 – Purdue University College of Pharmacy
January 2017 – December 2017 – Janssen Scientific Affairs, LLC, Medical Information
January 2018 – June 2018 – FDA, Division of Drug Information

Medication Safety 2016 – 2018 Fellow: Kaitlyn Dana, University of Connecticut School of Pharmacy, Class of 2016

July 2016 – February 2017 – Purdue University Center for Medication Safety Advancement
March 2017 – October 2017 – Eli Lilly and Company, Surveillance and Global Patient Safety
November 2017 – June 2018 –  FDA, Office of Surveillance and Epidemiology

Fellowship - Drug Information

Purdue University College of Pharmacy, Indiana University (IU) Health, and Eskenazi Health – Indianapolis, IN
The 6-month academic drug information portion of the Regulatory Pharmaceutical Fellowship will expose the fellow to academia and the responsibilities of institutional-based drug information centers. The program with Purdue University College of Pharmacy offers experience with the provision of drug information including formulary management and drug-use policy in conjunction with IU Health and Eskenazi Health. Fellows will conduct a research project suitable for presentation at a national meeting and publication in a peer-reviewed pharmacy journal and participate in the Indiana Pharmacy Teaching Certificate Program. The fellow gains significant experience in academia, providing didactic and experiential training to student pharmacists.

Janssen Scientific Affairs, LLC, Medical Information – Raritan, NJ
The 12-month rotation provides the opportunity for the fellow to gain experience as a member of a medical information team in a pharmaceutical industry setting. The program allows the fellow to develop skills related to development and delivery of drug information to healthcare professionals, payors, consumers, and business partners through a variety of methods. The fellow will have the option to participate in collaborative inter- and intra-departmental projects, mentor pharmacy students, and network with other pharmacists within the organization and through a pharmacist-focused resource group.

Food and Drug Administration, Division of Drug Information – Silver Spring, MD The 6-month rotation at FDA will provide an opportunity for the fellow to respond to drug information requests, mentor student pharmacists, and provide support for various FDA initiatives to health care professionals, consumers, and industry. The fellow will draft Drug Safety Communications for clinically significant drug safety alerts, and improve the risk assessment process through increasing voluntary reporting of serious spontaneous adverse events. The fellow will be a member of the Division of Drug Information’s Social Media team, which utilizes tools such as Twitter, Facebook, listservs, podcasts, and videos to disseminate the latest drug information to the public. The fellow will also lead the President’s Emergency Plan for AIDS Relief (PEPFAR) labeling initiative with the World Health Organization during their time at FDA. The fellow will also be a member of GADIS, FDA’s Global Alliance of Drug Information Specialists, promoting partnerships among pharmacists for the advancement of public health.

Fellowship Program Director:

Lindsay E. Wagner, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader | Senior Health Promotion Officer
Division of Drug Information | Office of Communications
Center for Drug Evaluation and Research | Food and Drug Administration 


Current Fellows:

2015-2017: Megan N. Brown, PharmD
Mercer University College of Pharmacy, Class of 2015
2014-2016: Jay R. Fajiculay, PharmD
Midwestern University, Chicago College of Pharmacy, Class of 2014

Past Fellows:

2013-2014: Bhavini T. Parikh, PharmD
Rutgers University, Ernest Mario School of Pharmacy, Class of 2013
2012-2014: Andrea M. TenBarge, PharmD
Associate Consultant, Medical Channels & Visual Media
Eli Lilly and Company
2011-2013: Genevieve Lynn Ness, PharmD
Director, Christy Houston Foundation Drug Information Center
Assistant Professor of Pharmaceutical, Social and Administrative Sciences
Belmont University College of Pharmacy
2010-2012: Kimberly (Wu) Chiu, PharmD
Consumer Safety Officer, Division of Drug Information
Food and Drug Administration
2009-2011: Lindsay E. (Davison) Wagner, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader, Division of Drug Information
Food and Drug Administration
2007-2009: Jean Cunningham, PharmD
Clinical Content Specialist
Truven Health Analytics
2005-2007: Sanjeev K. Bhanot, PharmD
Associate Director, Medical Affairs
Merz Pharma Canada, Ltd.
2003-2005: Tanya Nelson, PharmD
Manager, Medical Information
Janssen Scientific Affairs, LLC

Preceptors:

Amy Heck Sheehan, PharmD
Associate Professor of Pharmacy Practice
Purdue University College of Pharmacy
Samina Ali, PharmD
Associate Director, Medical Information
Janssen Scientific Affairs, LLC
Lindsay E. Wagner, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader, Division of Drug Information
Food and Drug Administration


Fellowship – Medication Safety

Purdue University, Center for Medication Safety Advancement – Indianapolis, IN
The 8-month rotation at Purdue University College of Pharmacy’s Center for Medication Safety Advancement (CMSA) will provide the fellow with exposure to academia and the various medication safety initiatives undertaken by CMSA. The fellow will actively participate in practice-based research to foster the discovery and delivery of information and practices to enhance medication safety. There will be numerous opportunities to publish original research and deliver presentations. Additionally, the fellow will have the opportunity to educate students, both didactically and through preceptorship.
Eli Lilly and Company, Surveillance and Global Patient Safety – Indianapolis, IN
The fellow will spend an 8 month rotation at Eli Lilly and Company working on the Surveillance team within Global Patient Safety. During this time, the fellow will have opportunities to work cross-functionally between pre- and post-marketed compounds to detect and evaluate adverse effects and other problems to determine if they are drug-related. The fellow will be involved in routine surveillance work as well as participating in the development of regulatory documents to gain a foundational understanding of pharmacovigilance responsibilities within industry.
Food and Drug Administration, Office of Surveillance and Epidemiology –Silver Spring, MD
The fellow will spend the last 8 months of their tenure working in the Office of Surveillance and Epidemiology (OSE) at the FDA. During this time, the fellow will have the opportunity to participate in intra- and inter-center projects in both the pre- and post-market arenas. Additionally, the fellow will utilize adverse drug event reporting data, medical literature, and established knowledge of marketed drug products to assess postmarket safety-related issues and conduct active surveillance work.

Past Fellows:

2013 – 2015: Katelyn Brown, PharmD
Consultant, Diabetes Real World Outcomes
Eli Lilly and Company

Preceptors:

John Hertig, PharmD, MS
Associate Director, Center for Medication Safety Advancement
Courtesy Clinical Assistant Professor of Pharmacy Practice
Purdue University
Kyle Hultgren, PharmD
Director, Center for Medication Safety Advancement
Courtesy Clinical Assistant Professor of Pharmacy Practice
Purdue University
Jennifer B. Mouser, PharmD
Manager, Safety Surveillance
Global Patient Safety
Eli Lilly and Company
William P. Brookfield, MS
Consultant, Safety Surveillance
Global Patient Safety
Eli Lilly and Company
Irene Z. Chan, PharmD, BCPS
Commander, U.S. Public Health Service
Deputy Director, Division of Medication Error Prevention and Analysis
Office of Surveillance and Epidemiology
Food and Drug Administration
Chris Jones, PharmD, MPH
Commander, U.S. Public Health Service
Deputy Director, Division of Pharmacovigilance
Office of Surveillance and Epidemiology
Food and Drug Administration


Fellowship – Drug Advertising and Promotion

Plans to recruit in late fall 2016 for one position in 2017 – 2019

The two-year, Advertising & Promotion track, prepares the fellow with an opportunity to develop an understanding of the FDA regulations, industry codes, policies, and Federal and State laws as it relates to prescription drugs and biologics advertising and promotion activities. The fellow will also have an opportunity to gain experience in the government promotional review process and become familiar with sections of the Federal Food, Drug, and Cosmetic Act and relevant FDA Guidance documents. Finally, the fellow will gain significant experience in academia providing didactic and experiential training of students.


Fellowship Benefits

  • Competitive stipend
  • Reimbursement for relocation and professional travel expenses
  • Enrollment in Indiana Pharmacy Teaching Certificate (IPTeC) Program
  • Purdue University benefit package
    • Health insurance
    • Prescription coverage
    • Vision plan
    • Dental (optional)
  • Vacation and University holidays
  • One year membership in the Regulatory Affairs Professionals Society (RAPS) and a copy of Fundamentals of Regulatory Affairs (US)

Application Process
The application process will begin in late fall 2016 for the 2017-2019 cycle.
The fellow must be a graduate from an ACPE-accredited college of pharmacy, or otherwise eligible for licensure, prior to the start of the fellowship term. U.S. citizenship is not required and VISA sponsorship may be possible.
Preliminary interviews are conducted during the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting (MCM) annually. Participation in PPS is not required but is encouraged for applicants.
All interested applicants must submit the following:

  1. Letter of intent for one of the two tracks
  2. Contact information for three references including email and phone number
  3. Curriculum Vitae
  4. Official Transcripts (electronic copies accepted)

Application deadlines will be announced when recruitment has begun in late fall 2016.
Drug Information Applicants - DrugInformationFellowship@gmail.com
Drug Advertising and Promotion Applicants – DrugMarketingFellowship@gmail.com

On-site interviews will take place at the FDA in Silver Spring, MD.

Contact Information
For further information, contact our current fellows at DrugInformationFellowship@gmail.com, DrugMarketingFellowship@gmail.com, or MedicationSafetyFellowship@gmail.com or contact the Program Director, LCDR Lindsay Wagner at Lindsay.Wagner@fda.hhs.gov.

Page Last Updated: 02/11/2016
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