Pharmaceutical Industry

Transcription

1 Pharmaceutical Industry Fellowship Program

2 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 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

3 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

4 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 Global Drug Safety Global Monitoring Operations Health Economics and Outcomes Research Marketing Medical Affairs New Products Market Research New Products Scientific Assessment Project Management Quality Assurance/Compliance Regulatory Affairs Regulatory Advertising/Promotion External rotations with the FDA are also permitted

5 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 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:

6 CURRENT FELLOWS CLINICAL DEVELOPMENT Omar Khalid, PharmD St. John s University, College of Pharmacy and Health Sciences REGULATORY AFFAIRS Maxwell Adams, PharmD Massachusetts College of Pharmacy and Health Sciences University 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 Reene Nadpara, PharmD Rutgers University, Ernest Mario School of Pharmacy Betsy Kurian, PharmD St. John s University College of Pharmacy and Allied Health Professions 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

7 PAST FELLOWS CLINICAL DEVELOPMENT REGULATORY AFFAIRS Michael C. Camuso, PharmD Senior Pharmacist, Investigational Drug Services, Brigham and Women s Hospital Albany College of Pharmacy and Health Sciences Amol J. Parekh, PharmD Principal Associate, Regulatory Affairs Genzyme, a Sanofi Company Rutgers University, Ernest Mario School of Pharmacy Yunji Kim, PharmD Associate Manager, Regulatory Affairs, Regeneron Pharmaceuticals University of North Carolina at Chapel Hill, Eshelman School of Pharmacy Kerri Z. Kaplan, PharmD Associate Director, Regulatory Affairs Dompé Long Island University, Arnold & Marie Schwartz College of Pharmacy and Health Sciences Joseph P. Stalder, PharmD Principal Business Manager Genentech University of California, San Diego Jessica Kachadourian, PharmD Associate Director, Medical Affairs Novartis Northeastern University Peter J. McFarland, PharmD Medical Science Liaison, Teva Pharmaceuticals Massachusetts College of Pharmacy and Health Sciences Karen A. Allen, PharmD Manager, Quality Assurance GCP GLP CSPV Daiichi Sankyo, Inc. St. John s University, College of Pharmacy and Allied Health Professions Rachel Luchini, PharmD Sr. Clinical Scientist, Clinical Development Forest Research Institute, Inc. Rutgers University, Ernest Mario School of Pharmacy Donato M. Forlenza, PharmD, MBA Manager, Regulatory Affairs, Advertising and Promotion Compliance, Boehringer Ingelheim Pharmaceuticals 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 Regulatory Health Project Manager Division of Neurology Products Center for Drug Evaluation and Research, FDA The Ohio State University Julie Plotnikov, PharmD Product Manager LEO Pharma A/S Temple University School of Pharmacy Hiren D. Patel, PharmD, MS, RAC LCDR USPHS 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 Hilary Winters Henshaw, PharmD Associate Regulatory Program Director Product Development, Genentech University of Michigan, College of Pharmacy Sejal P. Emerson, PharmD Director, Regulatory Affairs AbbVie University of Michigan, College of Pharmacy Vincent C. Yan, PharmD Senior Marketing Manager Amgen Rutgers University, Ernest Mario School of Pharmacy Amjad Iqbal, PharmD Director, Regulatory Affairs Forest Research Institute, Inc. University of Cincinnati, College of Pharmacy

8 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 ing 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 For more information about our Fellowship Program, contact the current Fellows at [email protected] or visit: