Oct 7, 2014 ... Jersey City, NJ • USA ... Regulatory Affairs, Global Drug Safety, and Global
Monitoring Operations .... Associate Regulatory Program Director.
Pharmaceutical Industry
Fellowship Program 2014 - 2015
Actavis and Forest Are Now One Global Company On July 1, 2014, Actavis completed the acquisition of Forest Laboratories, creating an innovative new model in specialty pharmaceuticals leadership built to compete within today’s evolving healthcare landscape. Learn more at www.Actavis.com
About Actavis Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing affordable generic and innovative branded pharmaceutical products for patients around the world. The Company markets a broad portfolio of branded and generic pharmaceuticals and develops new medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world. Additionally, the Company’s
Our Global Marketplace
North American Brands commercial sales, marketing and drug development & research functions are located in our Jersey City, NJ offices. Dundalk • Ireland
Larne • Northern Ireland
Hafnarfjordur • Iceland London • UK Long Island, NY • USA Jersey City, NJ • USA
Liège • Belgium
Parsippany, NJ • USA
Bucharest • Romania
Salt Lake City, UT • USA Oakland, CA • USA Elizabeth, NJ • USA
Troyan • Bulgaria
Liverpool • UK
Bangalore • India
Nerviano • Italy
Chennai • India
Owings Mills, MD • USA
Jakarta • Indonesia
Weston, FL • USA
Miramar, FL • USA
Navi, Mumbai • India
Ambernath • India
Our World-Class R&D Organization 2014-2015 Pharmaceutical Industry Fellowship Program
2014-2015 Actavis Fellowship Program Now entering its 12th year, the Actavis Fellowship Program (formerly known as the Forest Research Institute Fellowship) is one of the most dynamic and challenging development programs in the industry. In partnership with St. John’s University College of Pharmacy and Health Sciences, we offer two 2-year fellowships focused in Regulatory Affairs and Clinical Development. Both programs are based in our Jersey City, New Jersey office and designed to offer a broad range of hands-on training and professional development opportunities.
Regulatory Affairs Our Regulatory Affairs team leads our Company’s business-critical relationships with the U.S. Food and Drug Administration (FDA) and other regulatory agencies throughout the world, ensuring the continued success of our product portfolio and pipeline. Team Fellow activities include: • Supporting the development, filing and regulatory approval of new products • Filing and maintaining Investigational New Drug Applications (INDs) and New Drug Applications (NDAs) • Ensuring team compliance with all appropriate regulations and laws
Clinical Development (l-r) 1st row: P.Hornick, Vice President TA Head, M. Adams; 2nd row: O.Khalid, A.Chan, R.Hofbauer
Regulatory Affairs (l-r) 1st row: A. Howell; R. Nadpara; 2nd row: M. Olchaskey; A. Iqbal; Not pictured: J. Bray, Sr. VP, Reg. Affairs; B. Kurian
Clinical Development Our Clinical Development team is responsible for the development and execution of our global Phase II - IV clinical trials across our therapeutic categories. Team Fellows activities include: • Participating in the creation, execution and management of clinical trials • Developing trial protocols and materials • Training and managing investigative sites • Analyzing, interpreting, and reporting clinical trial data • Collaborating with a number of internal teams including Biostatistics, Data Management, Regulatory Affairs, Global Drug Safety, and Global Monitoring Operations
2014-2015 Pharmaceutical Industry Fellowship Program
Second Year Rotation The Actavis Fellowship Program is unique in that it offers the opportunity for fellows to rotate to other functional teams during their second year, helping to accelerate their professional growth and broaden their industry experience. Possible second-year rotations (3-12 months in duration) include: • Clinical Development
• New Products Scientific Assessment
• Global Drug Safety
• Project Management
• Global Monitoring Operations
• Quality Assurance/Compliance
• Health Economics and Outcomes Research
• Regulatory Affairs
• Marketing
• Regulatory Advertising/Promotion
• Medical Affairs
• External rotations with the FDA are also permitted
• New Products Market Research
2014-2015 Pharmaceutical Industry Fellowship Program
ABOUT ST. JOHN’S UNIVERSITY St. John’s University College of Pharmacy and Health Sciences, located in Queens, NY, is affiliated and partners with a number of elite healthcare organizations throughout the New York metropolitan area. Founded in 1929, the University offers undergraduate and graduate level healthcare-related programs. Undergraduates and graduates are actively involved in basic science, clinical research, and providing pharmaceutical care to an urban patient population.
St. John’s University Component Fellows are full-time University employees and provided a competitive stipend and benefit package, including comprehensive health insurance. Each Fellow is required to complete a one-semester teaching component at the University during their first year and a collaborative research project by the end of the second year. Additionally, each Fellow is able to participate in a number of other professional and educational development opportunities at the University, including mentorships; presentations; continuing education courses; resident and fellow seminars; Affiliate Faculty appointments; and a teaching certificate course. Fellows may also enroll and participate in University courses and degree programs.
Certificate of Completion Upon successful completion of the program, Fellows receive a certificate from St. John’s University College of Pharmacy and Health Sciences and Actavis.
“The St. John’s component provides a venue not only to teach students in an academic setting, but also to work on public speaking and your presentation style. This experience has shown benefit far beyond the classroom, especially since conveying information is at the heart of the profession of pharmacy.” – Joseph P. Stalder, PharmD Clinical Development Fellow 2009-2011
St. John’s University College of Pharmacy And Health Sciences Location: Queens, NY Dean: Russell J. DiGate, Ph.D. Graduate Programs Offered: M.S./Ph.D. in Pharmaceutical Sciences; M.S. in Biological and Pharmaceutical Biotechnology, Pharmacy Administration, and Toxicology; Master of Public Health (MPH) Website: www.stjohns.edu/academics/schools-and-colleges/collegepharmacy-and-health-sciences 2014-2015 Pharmaceutical Industry Fellowship Program
CURRENT FELLOWS CLINICAL DEVELOPMENT
2014 - 2016 Omar Khalid, PharmD St. John’s University, College of Pharmacy and Health Sciences
2013 - 2015 Maxwell Adams, PharmD
Massachusetts College of Pharmacy and Health Sciences University
REGULATORY AFFAIRS
2014 - 2016
“The St. John’s/Forest Research Institute Fellowship gave me the skill sets necessary to achieve a successful career in the pharmaceutical industry. The fast-paced, high-energy environment, paired with a very dedicated group of preceptors, afforded me a customized learning experience that provided the confidence necessary to seek high-profile challenging, and rewarding positions in the industry.”
– Amjad Iqbal, PharmD Regulatory Affairs Fellow 2004-2006
2013 - 2015
Reene Nadpara, PharmD
Betsy Kurian, PharmD
Rutgers University, Ernest Mario School of Pharmacy
St. John’s University College of Pharmacy and Allied Health Professions
2014-2015 Fellowship Team (l-r) 1st row: P. Hornick, A. Howell, L. Kunka, R. Nadpara, R. Masoud, A. Chan, N. Success, D. Maiden; 2nd row: R. Hofbauer, M. Adams, O. Khalid, A. Iqbal, D. Yuen, M. Olchaskey
Our Industry-Leading Commitment to R&D • 25+ specialty brand products in the near- or mid-term stage of development • ~12 product candidates at the Phase III or NDA stages of development • Alzheimer’s disease, cardiovascular disease, GI, infectious disease, Schizophrenia and bipolar disorders and COPD
2014-2015 Pharmaceutical Industry Fellowship Program
PAST FELLOWS 2012 - 2014
Michael C. Camuso, PharmD
2011 - 2013
Yunji Kim, PharmD
2010 - 2012
Kerri Z. Kaplan, PharmD
2009 - 2011
Joseph P. Stalder, PharmD
2008 - 2010
Jessica Kachadourian, PharmD
2007 - 2009
Peter J. McFarland, PharmD
2006 - 2008
Karen A. Allen, PharmD
St. John’s University, College of Pharmacy and Allied Health Professions
University of Michigan, College of Pharmacy
2005 - 2007
REGULATORY AFFAIRS
Rachel Luchini, PharmD
Sejal P. Emerson, PharmD
Sr. Clinical Scientist, Clinical Development Forest Research Institute, Inc.
Director, Regulatory Affairs AbbVie
Rutgers University, Ernest Mario School of Pharmacy
University of Michigan, College of Pharmacy
2004 - 2006
CLINICAL DEVELOPMENT
Vincent C. Yan, PharmD
Amjad Iqbal, PharmD
Senior Marketing Manager Amgen
Director, Regulatory Affairs Forest Research Institute, Inc.
Rutgers University, Ernest Mario School of Pharmacy
University of Cincinnati, College of Pharmacy
Amol J. Parekh, PharmD
Senior Pharmacist, Investigational Drug Services, Brigham and Women’s Hospital
Principal Associate, Regulatory Affairs Genzyme, a Sanofi Company
Albany College of Pharmacy and Health Sciences
Rutgers University, Ernest Mario School of Pharmacy
Donato M. Forlenza, PharmD, MBA
Associate Manager, Regulatory Affairs, Regeneron Pharmaceuticals
Manager, Regulatory Affairs, Advertising and Promotion Compliance, Boehringer Ingelheim Pharmaceuticals
University of North Carolina at Chapel Hill, Eshelman School of Pharmacy
Associate Director, Regulatory Affairs Dompé Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences
Albany College of Pharmacy and Health Sciences
Shweta Pandya, PharmD Manager, Advertising and Promotion, Regulatory Affairs Forest Research Institute, Inc. St. John’s University, College of Pharmacy and Allied Health Professions
Nicole L. Bradley, PharmD
Principal Business Manager Genentech
Regulatory Health Project Manager Division of Neurology Products Center for Drug Evaluation and Research, FDA
University of California, San Diego
The Ohio State University
Julie Plotnikov, PharmD
Associate Director, Medical Affairs Novartis
Product Manager LEO Pharma A/S
Northeastern University
Temple University School of Pharmacy
Hiren D. Patel, PharmD, MS, RAC LCDR USPHS
Medical Science Liaison, Teva Pharmaceuticals Massachusetts College of Pharmacy and Health Sciences
Regulatory Health Project Manager Division of Psychiatry Products Center For Drug Evaluation and Research, FDA St. John’s University, College of Pharmacy and Allied Health Professions
Manager, Quality Assurance GCP GLP CSPV Daiichi Sankyo, Inc.
Hilary Winters Henshaw, PharmD Associate Regulatory Program Director Product Development, Genentech
2014-2015 Pharmaceutical Industry Fellowship Program
Application Process and Eligibility Requirements To be considered for the Actavis Fellowship Program, you must meet the following requirements: • Graduate of an Accreditation Council for Pharmacy Education (ACPE)accredited Doctor of Pharmacy Program prior to the start of the fellowship term • Have a strong interest in pursuing a career in the pharmaceutical industry Interviews begin Saturday, December 7th, 2014 at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Anaheim, California. Candidates are encouraged to set up an interview in advance by emailing Dr. Joseph Brocavich at
[email protected].
Application Deadlines Curriculum Vitae (Resume) December 17, 2014 Letter of Intent
December 17, 2014
Official College Transcript
December 22, 2014
Letters of Recommendation (3)
December 22, 2014
Electronic Copies Should Be Sent To: Dr. Joseph Brocavich:
[email protected]. Dr. Michael Olchaskey:
[email protected]
Hard Copies Should Be Mailed to: Joseph M. Brocavich, PharmD Senior Associate Dean for Pharmacy Associate Clinical Professor College of Pharmacy and Health Sciences St. John’s University 8000 Utopia Parkway Queens, NY 11439
For more information about our Fellowship Program, contact the current Fellows at
[email protected] or visit: www.stjohns.edu/academics/schools-and-colleges/college-pharmacy-and-health-sciences/residency-and-fellowship-programs 2014-2015 Pharmaceutical Industry Fellowship Program