About FDA

Regulatory Pharmaceutical Fellowship

Currently Recruiting for 2015 – 2017: Drug Information Track and Drug Advertising and Promotion Track

Food and Drug Administration/Industry/Academia Fellowship 2015-2017
Jointly Sponsored By: Food and Drug Administration (FDA), Purdue University, Janssen Scientific Affairs, LLC, and Johnson & Johnson Health Care Compliance & Privacy

Introduction

The purpose of the Regulatory Pharmaceutical Fellowship is to train selected candidates in one of two tracks focused on the medical and regulatory aspects of drug information dissemination or marketing. 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 and the regulatory oversight of prescription drug marketing practices. 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 a 9-month rotation with FDA's Center for Drug Evaluation and Research, a 6-month rotation with Purdue University College of Pharmacy, and a 9-month rotation at Janssen Scientific Affairs, LLC or Johnson & Johnson Health Care Compliance & Privacy.

The program has two positions available for 2015-2017: one in Drug Information and one in Drug Advertising and Promotion. 

Fellowship Schedule

Drug Information Track – 1 position

July 2015 – December 2015 - Purdue University College of Pharmacy
January 2016 – September 2016 - Janssen Scientific Affairs, LLC
October 2016 – June 2017 - FDA, Division of Drug Information

Drug Advertising and Promotion Track – 1 position

July 2015 – March 2016 – Johnson & Johnson Health Care Compliance & Privacy
April 2016 – December 2016 - FDA, Office of Prescription Drug Promotion
January 2017 – June 2017 - Purdue University College of Pharmacy

Fellowship - Drug Information

 
Purdue University, Indiana University (IU) Health, and Eskenazi Health - Indianapolis, IN
The 6-month academic drug information portion of the Regulatory Pharmaceutical Fellowship will provide the fellow with exposure to academia and the different functions and 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. In addition, the fellow gains significant experience in academia, providing didactic and experiential training to Purdue University student pharmacists.
 
Janssen Scientific Affairs, LLC – Raritan, NJ
The 9-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 9-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, blogs, and audio and video podcasts 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, U.S. Public Health Service
Team Leader | Health Promotion Officer
Division of Drug Information | Office of Communications 
Center for Drug Evaluation and Research | Food and Drug Administration 

Current Fellows: 

2014-2016: Jay R. Fajiculay, PharmD
Midwestern University, Chicago College of Pharmacy, Class of 2014
 
2013-2014: Bhavini T. Parikh, PharmD
Rutgers University, Ernest Mario School of Pharmacy, Class of 2013 

Past Fellows:

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, 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
 
Tanya Nelson, PharmD
Manager, Medical Information
Janssen Scientific Affairs, LLC
 
Lindsay E. Wagner, PharmD
Lieutenant, U.S. Public Health Service
Team Leader, Division of Drug Information
Food and Drug Administration


Fellowship - Advertising & Promotion

Johnson & Johnson Health Care Compliance & Privacy – Titusville, NJ
The 9-month industry rotation is a part of the Pharmaceutical Group Health Care Compliance (HCC) organization within Johnson & Johnson (J&J). It is focused on providing a unique opportunity for the fellow to develop knowledge and expertise within both the Health Care Compliance and Regulatory Advertising and Promotion areas of the pharmaceutical industry. The fellow will have an opportunity to develop a deeper understanding of the importance of Health Care Compliance program, industry codes, J&J HCC policies, and Federal and State laws as it relates to pharmaceutical companies interactions with Health Care Professionals (HCPs). In addition, the fellow will develop skills to interpret FDA regulations and guidance as it relates to Advertising and Promotion of prescription drugs and biologics to HCPs and consumers. This program provides the fellow an opportunity to work directly with internal business partners such as marketing, sales training, medical affairs, field based commercials and medical representatives, and Law department on various projects to ensure promotional communications, and interactions with HCPs are in compliance with various laws and regulations.  

 
Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD
The 9-month rotation will offer the fellow a unique opportunity to gain experience in the government promotional review process. The fellow will become familiar with applicable sections of the Federal Food, Drug, and Cosmetic Act and relevant FDA Guidance documents. The fellow will assist in the review of promotional materials directed towards both healthcare providers and consumers, evaluate draft product labeling, research and evaluate complaints from industry, healthcare providers and consumers, and work with the trade name review group or the patient-related outcome claim evaluation team. The fellow may attend both departmental and interdepartmental meetings. The fellow will be mentored by senior members of the Office of Prescription Drug Promotion (OPDP) and will work collaboratively to develop departmental projects tailored to the fellow’s interests. Exposure to other areas of the Agency and professional networking will also be a major focus.
 
Purdue University – Indianapolis, IN
The 6-month academic portion of the Regulatory Pharmaceutical Fellowship will provide the fellow with exposure to academia and the different functions and responsibilities of institutional-based pharmacy administration. The program offers experiences in formulary management, medication safety, and drug-use policy in conjunction with Eskenazi Health. In addition the fellow gains significant experience in academia providing didactic and experiential training of Purdue University students.

Current Fellow: 

2013-2015: Samuel Davis, PharmD
University of Tennessee-Health Science Center, Class of 2013

Past Fellows: 

2011 – 2013: Ankur Kalola, PharmD
Regulatory Review Officer, Office of Prescription Drug Promotion
Food and Drug Administration

2009-2011: Nital Patel, PharmD, MBA
Medical Science Liaison
Mallinckrodt Pharmaceuticals

2007-2009: Sheetal Patel, PharmD
Director, Regulatory Compliance Lead
Johnson & Johnson Health Care Compliance & Privacy

2005-2007: Samuel Skariah, PharmD
Lieutenant Commander, U.S. Public Health Service
Team Leader, Office of Prescription Drug Promotion
Food and Drug Administration

2003-2005: Amit Patel, PharmD
Director, Health Care Compliance
Johnson & Johnson Health Care Compliance & Privacy

Preceptors: 

Sheetal Patel, PharmD

Director, Regulatory Compliance Lead
Johnson & Johnson Health Care Compliance & Privacy
 
Carrie Newcomer, PharmD
Regulatory Review Officer, Office of Prescription Drug Promotion
Food and Drug Administration
 
Amy Toscano, PharmD, CPA, RAC
Consumer Team Leader, Office of Prescription Drug Promotion
Food and Drug Administration
 
Steven R. Abel, PharmD, FASHP
Associate Vice President for Engagement
Professor of Pharmacy Practice
Purdue University 

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 2014 for the 2015-2017 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.

Preliminary interviews are conducted during the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting (MCM) annually. Participation in PPS is not required for application.

All interested applicants must submit the following:

  1. Letter of intent (indicating preferred track)
  2. Curriculum Vitae
  3. Official Transcripts (electronic copies accepted)
  4. Three references with contact information. We will call the references instead of requesting letters of recommendation.
All application materials should be submitted electronically no later than 11:59 pm EST on Wednesday, December 17, 2014 to:
 
Drug Information Applicants - DrugInformationFellowship@gmail.com
Drug Advertising & Promotion Applicants - DrugMarketingFellowship@gmail.com
On-site interviews will take place on Friday, January 9, 2015.
 
Contact Information
 
For further information, please contact the Fellowship Program Director, LT Lindsay Wagner (Lindsay.Wagner@fda.hhs.gov), or any of our current fellows at DrugInformationFellowship@gmail.com or DrugMarketingFellowship@gmail.com

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Page Last Updated: 12/15/2014
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