2021-2023 Pharmaceutical Fellowship - Rutgers Institute for ...
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Table of Contents Our Credo.......................................................................................................... 3 Diversity and Inclusion at Johnson & Johnson.....................................................4 Our Family of Companies................................................................................... 5 Message to Prospective Fellows......................................................................... 6 Greeting from Company Sponsors...................................................................... 8 Consumer Health Fellowships............................................................................ 9 • Skin Health Clinical Research and Claims Strategy................................................. 10 • Self-Care Clinical Research...................................................................................... 11 Janssen Pharmaceutical Fellowships................................................................. 12 • Commercial Insights and Strategy–Immunology & Infectious Diseases/Neuroscience...13 • Global Commercial Insights, Infectious Disease & Vaccines...........................................15 • US Immunology Marketing–Integrated Customer Solutions................................. 16 • US Oncology Brand Marketing................................................................................17 • Clinical Science .......................................................................................................19 • Early Clinical Research and Development..............................................................20 • R&D Global Development Medical Affairs Operations............................................21 • Medical Information & Knowledge Integration, Neuroscience.............................. 22 • BioResearch Quality & Compliance ........................................................................ 23 Johnson & Johnson, Inc. Fellowships................................................................ 24 • Regulatory Advertising and Promotion/Healthcare Compliance.......................... 25 • Office of the Chief Medical Officer, Pharmacovigilance......................................... 26 Non-Recruiting Fellowships............................................................................. 28 Former Fellow Testimonials............................................................................. 29 RPIF Alumni at Janssen.................................................................................... 30 Frequently Asked Questions............................................................................. 31 Rutgers Pharmaceutical Industry Fellowship Program ......................................32 2
Our Credo We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality. We must constantly strive to provide value, reduce our costs and maintain reasonable prices. Customers’ orders must be serviced promptly and accurately. Our business partners must have an opportunity to make a fair profit. We are responsible to our employees who work with us throughout the world. We must provide an inclusive work environment where each person must be considered as an individual. We must respect their diversity and dignity and recognize their merit. They must have a sense of security, fulfillment and purpose in their jobs. Compensation must be fair and adequate and working conditions clean, orderly and safe. We must support the health and well-being of our employees and help them fulfill their family and other personal responsibilities. Employees must feel free to make suggestions and complaints. There must be equal opportunity for employment, development and advancement for those qualified. We must provide highly capable leaders, and their actions must be just and ethical. We are responsible to the communities in which we live and work and to the world community as well. We must help people be healthier by supporting better access and care in more places around the world. We must be good citizens–support good works and charities, better health and education, and bear our fair share of taxes. We must maintain in good order the property we are privileged to use, protecting the environment and natural resources. Our final responsibility is to our stockholders. Business must make a sound profit. We must experiment with new ideas. Research must be carried on, innovative programs developed, investments made for the future and mistakes paid for. New equipment must be purchased, new facilities provided and new products launched. Reserves must be created to provide for adverse times. When we operate according to these principles, the stockholders should realize a fair return. 3 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Diversity and Inclusion at Johnson & Johnson At Johnson & Johnson, Diversity & Inclusion means — You Belong. Our Credo, people, policies, and benefits have created an inclusive environment where differences are valued, and voices are heard so that all employees can reach their full potential. Diverse thinking drives innovation, and inclusion is the key to unlocking those diverse ideas. We are fully committed to push back against racial injustice as it has no place in our society. OCMO Fellows and Preceptors with Wanda Hope, Chief Diversity & Inclusion Officer, at PharmD Summit in Fall 2018 J&J also offers a wide variety of Employee Resource Groups (ERGs) that allow fellowship with likeminded individuals. These ERGs are listed below and for more information on these groups please see our FAQs page. 4 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Our Family of Companies Johnson & Johnson Consumer Health Pharmaceutical Medical Device Sector Sector Sector Johnson & Johnson Janssen ETHICON Consumer Pharmaceuticals Biosense Webster Janssen Biotech DePuy Synthes Actelion = Indicates an operating company that does offer fellowships = Indicates an operating company that does not offer fellowships Please note that this chart is not an exhaustive list. J&J has over 200 operating companies. For additional information please visit: http://jnj.com Our Portfolio Consumer Health Products Pharmaceutical Products This is not an exhaustive list of products. Learn about Johnson & Johnson’s history advancing healthcare at https://ourstory.jnj.com/ 5 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Message to Prospective Fellows Johnson & Johnson and the Ernest Mario School of Pharmacy would like to thank you for your interest in the Rutgers Pharmaceutical Industry Fellowship Program. We are excited to be a part of your professional development. At its core, our Credo defines our responsibilities as Johnson & Johnson employees and directs our actions. It challenges us to put the needs and well-being of the people we serve first, and our more than 130,000 employees are united in a common mission: to help people everywhere live longer, healthier, happier lives. At J&J, your future is bright. Equipped with resources, training, and support, we foster the ideal environment for pharmacists to develop and succeed. Thank you for considering J&J, and we wish you great success as you take the next step in your career. Today’s dynamic healthcare field is changing faster than ever, and these changes bring new challenges as well as new opportunities to learn and grow—especially for our early talent to develop into the future leaders in healthcare. We know that by working together to tap into the knowledge, experience, and passion of people throughout our organization, we can solve some of healthcare’s toughest problems. 6 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Message to Prospective Fellows (cont’d) “ We appreciate that you are considering the Janssen Pharmaceutical Companies of Johnson & Johnson in your fellowship search. We focus on developing transformational medicines to treat the world’s most devastating and complex diseases. Patients are our first responsibility and inspire our work each day. Here, you will gain a rewarding industry experience, build a strong career foundation, and develop a clear understanding of what matters most— Jennifer Taubert improving health for humanity. ” Executive Vice President Worldwide Chairman, Pharmaceuticals “ Johnson & Johnson Consumer Health advances the personal health of 1.2 billion consumers every day with iconic products that are rooted in science and endorsed by professionals. Our brands are at the core of consumers’ daily lives and help empower them to take care of themselves and their loved ones. At a time when consumers are increasingly health-conscious and empowered, our Consumer Health fellowships offer you an opportunity to gain valuable experience in innovating to meet the needs of today’s modern consumer. We hope you’ll join us in our work to make a sustainable, positive and enduring impact on personal health. ” Thibaut Mongon Executive Vice President Worldwide Chairman, Consumer Health “ At Janssen, we focus our innovation on some of the most devastating diseases and the most complex medical challenges of our time with one goal in mind—improving the health of people around the world. Patients are at the core of everything we do, and they serve as the inspiration for our work every day. As part of our fellowship program, you will gain critical industry experience, develop a strong career foundation, and be a part of a team delivering transformational medicines to people who need them. We’re on a Scott White mission to improve the health of people around Company Group Chairman The Americas Pharmaceuticals the world—we hope you’ll join us. ” 7 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Greeting from Company Sponsors “ Johnson & Johnson is an amazing company for pharmacists seeking to augment their education with training and experience in the pharmaceutical industry. It is a Credo-based company that fosters an inclusive culture of diverse talent and values the unique skill set and expertise that post-doctoral fellows bring into the organization. We proudly offer a flourishing cross-sector, cross-functional leadership program designed to develop a pipeline of future leaders. With the continuous feedback from our fellows, alumni, and internal stakeholders, the program continues to evolve and expand each year to ensure the experience is empowering and rewarding. We look forward to meeting you to discuss how Johnson & Johnson can serve as your pathway to an enriching career in changing the trajectory of human health. ” Julie Thomas, PharmD Vice President Global Medical Safety Operations Global Medical Organization Janssen Pharmaceuticals Stefanie Emanuel, PharmD Director Global Case Management Office of Consumer Medical Safety Mary Mettias, PharmD Product Director HCP Professional Promotions 8 Cardiovascular J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Consumer Health Fellows and Preceptors photographed in Fall 2019 Johnson & Johnson Consumer Health Available Fellowship Positions (2021–2023) Skin Health Clinical Research and Claims Strategy Fellowship Skillman, NJ — 1 position Self-Care Clinical Research Fellowship Fort Washington, PA — 1 position 9 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Skin Health Clinical Research and Claims Strategy Fellowship Skillman, NJ – 1 position Fellowship Description This 2-year fellowship position emphasizes clinical research, Current Fellow protocol development, and claims support/strategy, with a focus on consumer skin health products. The successful candidate will develop their clinical research skills to develop protocols, while also enhancing their clinical strategy skills by applying clinical research results for a successful consumer product launch. The fellow will engage in the entire claims strategy process to understand and apply clinical and other scientific research results (i.e. safety, lab testing, marketing, and publications) to communication and product claims. This fellowship provides a broad knowledge base in corporate activities and promotes the role of the PharmD in the consumer health and pharmaceutical Lisa Caratelli, PharmD industry. University of Michigan Second-Year Fellow Goals of the Skin Health Clinical Research and Claims Strategy Fellow Specific duties and goals include but are not limited to: 1) Develop and substantiate claims, formulate clinical strategies, support clinical trial related activities, review/approve communications for consumer and healthcare professionals 2) Generate and translate scientific and technical knowledge to substantiate claims and develop communications for consumers and healthcare professionals 3) Demonstrate an understanding of clinical trial data by evaluating, analyzing, and reporting results of clinical trials 4) Participate and lead cross-functional teams for the evaluation of new product ideas and project implementation, ensuring timeline adherence and project completion Preceptor Rabab Hussain, PharmD, RPh Principal Scientist Clinical Research and Claims Strategy 10 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Self-Care Clinical Research Fellowship Fort Washington, PA – 1 position Fellowship Description This two-year postgraduate fellowship is designed to provide the Current Fellow fellow with a thorough knowledge of the clinical research process and to cultivate scientific and professional skill sets necessary to enable the fellow to provide strategic input into research plans and study designs in support of product development and claims substantiation activities. Additionally, the fellowship is designed to develop core competencies that allow the fellow to interpret and communicate scientific information to cross-functional teams as well as consumers and the professional community. The clinical research team based in Fort Washington, PA, is responsible for developing and executing the clinical research Giuliana Campo, PharmD plan and associated claims strategy across various need states, Albany College of Pharmacy including pain and allergy in the U.S. and globally. and Health Sciences Second-Year Fellow Goals of the Self-Care Clinical Research Fellow Specific duties and goals include but are not limited to: 1) Serve as a member of the Clinical Research team dedicated to the development and implementation of clinical strategies in support of claims and regulatory filings 2) Provide active scientific contributions to cross-functional project teams within the Pain and/or Allergy therapeutic area 3) Communicate and translate scientific and technical knowledge to substantiate claims for consumers and healthcare professionals 4) Participate in cross-functional teams for the evaluation of new product ideas and project implementation 5) Facilitate an understanding of clinical trial data and evaluate, analyze and report results of clinical trials 6) Develop knowledge of Good Clinical Practices and Ensure all activities are conducted in accordance with high ethical/quality standards and all applicable policies and procedures Preceptor Steven Sacavage, PharmD, MS Associate Director Clinical Research 11 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Janssen Fellows photographed in Fall 2019 Janssen Pharmaceutical Companies of Johnson & Johnson Available Fellowship Positions (2021–2023) Commercial Insights and Strategy Fellowship Immunology Infectious Diseases/Neuroscience Horsham, PA – 1 position Titusville, NJ – 2 positions Global Commercial Insights, ID&V Fellowship NEW Raritan, NJ – 1 position US Immunology Marketing, Integrated Customer Solutions Fellowship Horsham, PA – 1 position US Oncology Brand Marketing Fellowship Multiple Myeloma, Professional Prostate Cancer, Market Access & Promotion Patient Experience Horsham, PA – 1 position Horsham, PA – 1 position CAR-T, Patient Experience NEW Lung Cancer, Patient Experience NEW Horsham, PA – 1 position Horsham, PA – 1 position Clinical Science Fellowship NEW Horsham, PA – 1 position Early Clinical Research and Development Fellowship NEW Raritan, NJ – 1 position R&D Global Development, Medical Affairs Operations Fellowship NEW Titusville, NJ – 2 positions Medical Information & Knowledge Integration, Neuroscience Fellowship Titusville, NJ – 1 position BioResearch Quality & Compliance Fellowship Raritan, NJ – 1 Position 12 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Commercial Insights and Strategy Fellowship Immunology — Horsham, PA – 1 position Infectious Diseases/Neuroscience — Titusville, NJ – 2 positions Fellowship Description The two-year Commercial Insights and Strategy (CIS) Fellowship position is a dynamic development opportunity where the fellow learns how to leverage their existing knowledge base to effectively generate insights used for driving key business decisions. The position allows the fellow to gain experience in several areas of the CIS group, including marketing analytics, sales analytics, market research, and business intelligence. The CIS fellow maintains open communication with the entire commercial organization to ensure alignment aiding in developing strategies to keep business ahead of the curve. To be successful, the fellow must stay abreast of evolving literature related to the specific therapeutic area as well as staying up-to-date of the competitive landscape. As part of the Commercial Excellence group of Johnson & Johnson’s pharmaceutical sector, Janssen Pharmaceuticals, we emphasize a team- oriented structure in which the fellow works closely with business partners such as Marketing, Managed Markets, Sales, Sales Training, and Medical Affairs. Current Fellows Savita Senthil, PharmD Kelvin Pensuwan, PharmD University of Texas at Austin St. John's University First-Year Fellow Second-Year Fellow Immunology Immunology Natasha Dave Savaliya, PharmD, MBA Hannah Eppley, PharmD Fairleigh Dickinson University Butler University Second-Year Fellow First-Year Fellow Infectious Diseases/Neuroscience Infectious Diseases/Neuroscience 13 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Commercial Insights and Strategy Fellowship (cont’d) Immunology — Horsham, PA – 1 position Infectious Diseases/Neuroscience — Titusville, NJ – 2 positions Goals of the Commercial Insights and Strategy Fellow Specific duties and goals include but are not limited to: 1) Investigate and deliver key information/intelligence needs, while becoming a subject matter expert of the competitive and pharmaceutical business environment 2) Be a consultant by developing the required skills to synthesize information, generate insights, formulate solutions, present findings, and deliver impact 3) Lead primary research projects in business intelligence or market research 4) Shape market research studies to test and improve brand strategy and promotion 5) Influence the development and enhancement of Brand Marketing strategy by collaborating across the commercial organization, providing primary and secondary data expertise 6) Pursue opportunities to try new, innovative approaches to insight development 7) Begin shaping your career by forging valuable relationships across the enterprise Preceptors Rodney Firmin, CPA, MBA Senior Manager Portfolio Reporting, Immunology Dongmei Yang, MS, MBA Senior Manager Market Research and Integrated Analytics, Infectious Diseases Chris McKenzie, MBA Senior Manager Commercial Insights and Strategy 14 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Global Commercial Insights, Infectious Disease & Vaccines Fellowship Raritan, NJ — 1 position NEW FELLOWSHIP Fellowship Description The fellowship opportunity within the Global ID&V Commercial Insights track is a dynamic development role in which the fellow will collaborate with business partners across R&D, commercial, BD, and payer teams to generate insights used to support key business decisions. The primary focus of the fellowship is to provide an in-depth experience of the infectious disease and vaccines (ID&V) arena and to track, analyze, and disseminate business insights. As part of the Global Commercial Strategy Organization (GCSO), the fellowship experience will span across business intelligence topics focused on early asset strategy, late- stage go-to-market plans, and commercial products with implications to the Janssen portfolio. The ID&V GCSO team based in Raritan, NJ, is responsible for developing the global strategy of the Janssen ID&V portfolio and driving alignment with regional colleagues to ensure successful strategy execution. Goals of the Global Commercial Insights, Infectious Disease & Vaccines Fellow Specific duties and goals include but are not limited to: 1) Research, analyze, and distribute intelligence 4) Collaborate with business development partners on scientific, clinical, regulatory, and to help identify and conduct due diligence of commercial topics in the ID&V arena while both early and late-stage opportunities becoming a subject matter expert of the 5) Gather data and apply all applicable competitive and pharmaceutical business information to ensure competitive launch environment timelines are impactful 2) Be a consultant by developing the required 6) Pursue opportunities to try new, innovative skills to synthesize information, generate approaches to insight development insights, formulate solutions, present findings, and deliver impact 7) Begin shaping your career by forging valuable relationships across the enterprise 3) Co-lead primary and secondary research projects in business intelligence Preceptors Michael Zieziula Global Commercial Insights Leader Global Commercial Strategy Organization (GCSO) Rohit Vij Global Commercial Insights Associate Director Infectious Diseases & Vaccines Global Commercial Strategy Organization (GCSO) Muvi Ogbighele Global Commercial Insights Associate Director Infectious Diseases & Vaccines Global Commercial Strategy Organization (GCSO) 15 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
US Immunology Marketing, Integrated Customer Solutions Fellowship Horsham, PA — 1 position Fellowship Description The Integrated Customer Solutions (ICS) Fellowship, within Current Fellow Janssen Immunology Marketing, is a part of the commercial organization at Janssen Biotech of Johnson and Johnson. This is a unique two-year program with the ultimate goal being to develop, deliver and measure innovative strategies to help patients start and stay on their Janssen Biologic. The fellow will gain experience shaping the customer experience across the Immunology portfolio while partnering with various colleagues and customers, specifically Specialty Pharmacies, to deliver key messages and develop strategic programs. Business and communication skills will be strengthened to fully prepare the fellow to operate in a variety of positions across the Cecelia Trybus, PharmD pharmaceutical industry. Duquesne University Second-Year Fellow Goals of the US Immunology Marketing, Integrated Customer Solutions Fellow Specific duties and goals include but are not limited to: 1) Work collaboratively with key internal and external business partners, including but not limited to specialty pharmacy customers, in support of ongoing immunology marketing workstreams 2) Assist in the maintenance and development of innovative patient-centered programs with a focus on helping patients start and stay on therapy 3) Attain subject matter expertise in the immunology specialty pharmacy landscape, specifically in the gastroenterology, dermatology, and rheumatology therapeutic areas 4) Develop expertise in pharmacy data interpretation and application to help shape strategy and enhance business review discussions Preceptor Bryan Weinlein Product Director Integrated Customer Solutions, Specialty Pharmacy 16 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
US Oncology Brand Marketing Fellowship Multiple Myeloma, Professional Promotion – Horsham, PA – 1 position Prostate Cancer, Market Access & Patient Experience – Horsham, PA – 1 position NEW CAR-T, Patient Experience – Horsham, PA – 1 position NEW Lung Cancer, Patient Experience – Horsham, PA – 1 position Fellowship Description US Oncology Brand Marketing fellows who aspire to be future sales & marketing leaders within Janssen will have the support of Oncology PharmD management and executive sponsors. A Janssen Oncology fellow can expect to be integrated into the culture of the Oncology organization, as a critical contributor to the oncology business. The fellow will be provided training on both marketing and oncology’s innovative environment. At Janssen, marketing is essential to recognizing customer needs and creating valued brands. The US Oncology Brand Marketing Fellowship is a two-year program that utilizes a marketing development model to ensure fellows are obtaining and mastering the critical competencies and skills required of a successful marketer. While with Janssen Oncology, fellows will have the opportunities to manage and lead projects that showcase their tactical abilities guided by the overall brand strategy. Leveraging their clinical expertise, they will evaluate the dynamic landscape of stakeholders, identify actionable insights, and generate solutions that impact patient lives. Current Fellows Sophie Paik, PharmD, RPh Pelumi Wemida, PharmD St. John's University University of Houston Second-Year Fellow Second-Year Fellow Sarah Mahmoud, PharmD Ian Gliksman, PharmD Philadelphia College of Pharmacy Rutgers University First-Year Fellow First-Year Fellow 17 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
US Oncology Brand Marketing Fellowship (cont’d) Multiple Myeloma, Professional Promotion – Horsham, PA – 1 position Prostate Cancer, Market Access & Patient Experience – Horsham, PA – 1 position NEW CAR-T, Patient Experience – Horsham, PA – 1 position NEW Lung Cancer, Patient Experience – Horsham, PA – 1 position Goals of the US Oncology Brand Marketing Fellow Specific duties and goals include but are not limited to: 1) Become a subject matter expert in the patient and healthcare provider journey 2) Distill insights from data gathered through primary and secondary sources, in collaboration with Commercial Excellence, to inform and influence the strategy and tactic decision making 3) Support the commercial team during launch execution by managing and owning key promotional and non-promotional resources 4) Build networks across commercial team and across functions to add additional context to insights and recommendations, as well as build on existing knowledge to enhance in-market execution Preceptors Todd Spidare, MBA Product Director Multiple Myeloma, Professional Promotion Michael Hearty, RPh, MBA Group Product Director Prostate Cancer, Market Access Lauren Vultaggio Product Director CAR-T, Patient Experience Jake Bryant, PharmD, MBA Group Product Director Lung Cancer, Professional Promotion 18 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Clinical Science Fellowship Horsham, PA — 1 position NEW FELLOWSHIP Fellowship Description The focus of this entry position is to contribute to the scientific monitoring of clinical studies. The incumbent is responsible for the compliance of the assigned tasks with department, company and regulatory standards and procedures. Goals of the Clinical Science Fellow Specific duties and goals include but are not limited to: 1) As requested and under the supervision of an SRS, contributes to the development of the clinical study protocol and of other clinical study documents, eg, Informed Consent Form, Case Report Form, etc 2) Participates in medical monitoring/reporting including evaluation of adverse events 3) Depending on the individual's experience, is the primary Clinical Science contact for external service provider(s) of a clinical study 4) As requested and under the supervision of an SRS, contributes to and monitors daily activities of clinical studies which require scientific input, eg, contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees/Institutional Review Boards questions, etc 5) Ensures that all activities are in compliance with department, company and regulatory standards and procedures Preceptor Rui Li, MD Clinical Leader/ Study Responsible Physician 19 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Early Clinical Research and Development Fellowship Raritan, NJ – 1 position NEW Fellowship Description FELLOWSHIP The Translational and Experimental Medicine (TEM) organization is responsible for early clinical development activities beginning with new molecular entity (NME) declaration to conduct of First-in-Human and Proof of Concept Phase IIa trials for compounds in the Cardiovascular and Metabolism (CVM) therapeutic area pipeline. It is the responsibility of TEM to ensure timely and informed Go/No Go decisions, leading to the eventual transfer of the NME(s) to Late Stage Clinical Development. TEM is integral to the advancement of the CVM pipeline and the larger Janssen Research and Development (R&D) organization. The TEM therapeutic focus spans across various disease states such as non-alcoholic steatohepatitis, kidney, cardiopulmonary (including thrombosis and pulmonary arterial hypertension), and retinal diseases. The CVM TEM team is looking to grow and develop the next generation of Clinical Scientists and is committed to providing a robust experience with the end goal of graduating competitive and well-rounded Clinical Science professionals. The fellow will be immersed in clinical science activities ranging across protocol concept planning, study start-up, execution, and close out of early stage clinical trials. With exposure to both Clinical Science and Clinical Operations, the fellow will integrate skill sets to develop scientifically sound and operationally feasible trials. Furthermore, the fellow will learn to navigate through numerous cross-functional interactions, which are essential in daily operations of the TEM team. The various internal stakeholders the fellow will engage with include: Clinical Operations, Regulatory Affairs, Clinical Pharmacology, Global Medical Safety, Late Stage Clinical Development, Data Management, Clinical Supply, Chemistry Manufacturing and Controls (CMC), Discovery, and Biomarkers. At the end of the two-year program, the fellow will build the cornerstone competencies to become a Clinical Scientist. Goals of the Early Clinical Research and Development Fellow Specific duties and goals include but are not limited to: 1) Describe the drug development process with specific 6) Experience key activities within Clinical Operations focus on early clinical development including (but not limited to): site feasibility, site 2) Understand the clinical scientist role within clinical selection, health authority and Institutional Review development and build responsibility as a clinical Board/Ethics Committee submissions/questions, scientist throughout the experience clinical supply forecasting, and site initiation visits 3) Incorporate the medical and scientific principles of 7) Represent the clinical and scientific perspective clinical pharmacology, clinical and non-clinical safety, before internal and external stakeholders pharmacokinetics and pharmacodynamics into 8) Grow a network across functional area partners to clinical programs expand knowledge and practice meaningful networking 4) Work in collaboration with CVM TEM clinical leaders 9) Keep up to date with pertinent competitive space by to advance NMEs through clinical programs by attending scientific meetings and/or thought leader planning, start-up, execution (ie, clinical monitoring), forums and closure of clinical trials 5) Support drafting of key clinical documents including clinical trial protocols, investigator brochures, informed consent forms, medical review plans, and clinical study reports Preceptors Anastasiya Koshkina, PharmD Associate Director, Clinical Scientist Translational and Experimental Medicine Daniel Jonathan, PharmD Associate Director, Global Clinical Development Operations Trial Leader Early Development Oncology 20 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
R&D Global Development, Medical Affairs Operations Fellowship Titusville, NJ — 2 positions NEW FELLOWSHIP Fellowship Description This two year program is designed to provide the fellow with knowledge of clinical development through experience in clinical trial operations for the Medical Affairs portfolio of studies. The fellow will act as a Trial Manager for local/regional company-sponsored clinical trials gaining valuable insight and experience in the set- up and execution of clinical studies.In doing so, the fellow will learn clinical project management, critical path identification, and risk management. They will also gain experience in budget management and reconciliation including managing out-of-pocket and FTE costs. While there is no rotation, there are a number of different study types that the fellow will be introduced to including but not limited to interventional, non-interventional, virtual, and post-approval commitment. Goals for the R&D Global Development Medical Affairs Operations Fellow Specific duties and goals include but are not limited to: 1) Responsible for end-to-end project management including high level budget estimate, protocol development, trial set-up, execution, close-out, analysis and reporting. Includes oversight of key study team members 2) Track project progress against planned timelines. Monitors patient recruitment rate to ensure that target enrollment will be met across the allocated regions/countries 3) Provide regular status updates and ensures required reports are generated and available for real time tracking of project status 4) Maintain project compliance within all applicable Health Authority (HA) regulations, guidelines, internal SOPs and processes. Ensure quality oversight of assigned projects utilizing the available tools so that the project is in a constant state of inspection-readiness. Participate in preparation for, and conduct of, HA inspections and internal Quality Assurance (QA) audits 5) Identify and proactively manage issues in a timely manner. Escalate risks related to resources, timelines and budgets. Implement action plans to mitigate risks Preceptors Monika Miranda Global Development Operations Head Medical Affairs Operations - Americas R&D Global Development Deana Martz Global Development Trial Leader Medical Affairs Operations - Americas R&D Global Development Amy Maxson Global Development Trial Leader Medical Affairs Operations - Americas R&D Global Development 21 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Medical Information & Knowledge Integration, Neuroscience Fellowship Titusville, NJ — 1 position Fellowship Description Current Fellow This two-year program offers experience in the practice of medical information for a variety of settings. The fellow will directly engage in clinical information exchange with healthcare professionals and work with internal and external partners. The fellow will also have opportunities to lead and participate in projects in areas of interest. Medical Information professionals at Janssen are in a unique position to empower strategic business partners and customers with knowledge to impact patient care. The department is staffed with advanced degree medical professionals who are recognized as product and therapeutic Ghazal Maghareh, PharmD knowledge experts. These professionals leverage intelligence and Xavier University understanding of the customer, science, and healthcare environment to Second-Year Fellow create insights that generate a positive impact on public health. This program will provide the fellow with experiences at the following practice sites: Year 1 ix months at Drug Information Service at Robert Wood Johnson University Hospital •S (RWJUH), an academic medical center in New Brunswick, NJ ix months at the Medical Information Communication Channels at Janssen in Titusville, NJ •S Year 2 •M edical Information at Janssen in Titusville, NJ Goals of the Neuroscience Fellow Specific duties and goals include but are not limited to: 1) Strengthen verbal communication skills through scientific information exchange with healthcare providers and internal business partners 2) Enhance medical writing skills through activities such as the preparation of written clinical responses to medical information requests, literature summaries, training materials, and clinical monographs 3) Strengthen presentation skills by developing and delivering a variety of presentations to business partners throughout the organization 4) Develop collaboration and leadership skills through department initiatives, cross-functional projects, and participation in professional organizations Preceptors Tricia Lopena, PharmD, MBA Associate Director Medical Information & Knowledge Integration Emily R. Aboujaoude, PharmD Drug Information Residency Program Director Robert Wood Johnson University Hospital 22 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
BioResearch Quality & Compliance Fellowship Raritan, NJ – 1 position Fellowship Description Current Fellow The BioResearch Quality & Compliance (BRQC) Fellowship program is a two-year experiential program designed to provide a broad understanding of the global development process, quality strategies and processes, while gaining hands-on experience through participating on cross-functional teams. The BRQC team is a key strategic partner supporting global research and development at Janssen. The purpose of BRQC is to deliver an industry-leading Quality Management System by using and developing proactive risk-based methodologies, early risk identification through knowledge sharing, Kierstein Williams, PharmD best practice sharing, leveraging of resources and capabilities, and Xavier University talent development opportunities. First-Year Fellow During the fellowship, fellows will gain critical skills that will help set a foundation for their career in the pharmaceutical industry. Through the fellowship, fellows will explore new opportunity, grow as an individual and have many invaluable learning experiences to become the next generation of leaders to impact change on a global scale. This program will provide a rotational experience throughout each functional pillar of BRQC: • Compliance Strategy & Analytics • Quality Management Systems Oversight • Governance & Operations Management • Quality Planning & Strategy • Quality Analytics • Medical Devices • Quality Assurance • Consumer • Quality Management Goals of the BioResearch Quality & Compliance Fellow Specific duties and goals include but are not limited to: 1) Assist in the development and research of innovative methodologies which improve the quality management system 2) Collaborate with internal and external business partners such as Global Clinical Development Operations, Global Regulatory Affairs, Regulatory Compliance, Quantitative Sciences, and more to sustain quality in our culture 3) Support quality teams within BRQC in coordination, review and preparation of necessary documentation 4) Enhance leadership skills, capabilities and behaviors through selected development programs Preceptors Maria Varvaro-Sause, PharmD Head of Quality Management System Oversight BioResearch Quality & Compliance Saranya Srinivasan, PharmD QMS Monitoring Specialist BioResearch Quality & Compliance 23 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Regulatory Advertising and Promotion/Healthcare Compliance Fellows photographed in Fall 2019 Johnson & Johnson, Inc. Available Fellowship Positions (2021–2023) Regulatory Advertising and Promotion/Healthcare Compliance Fellowship Titusville, NJ — 1 position Office of the Chief Medical Officer Pharmacovigilance Fellowship Raritan, NJ and Skillman, NJ — 2 positions 24 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Regulatory Advertising and Promotion/ Healthcare Compliance Fellowship Titusville, NJ — 1 position Fellowship Description The Regulatory Advertising and Promotion/Healthcare Compliance Fellowship is part of the Pharmaceutical Group Health Care Compliance organization within Johnson & Johnson. This two- year fellowship will provide a unique opportunity for the fellow to develop knowledge of regulatory advertising and promotion fundamentals within the first year of the fellowship. The fellow will spend the second year to further enhance the understanding of regulatory advertising and promotion fundamentals and how it will apply to various digital channels such as social media platforms, websites, chatbots, streaming radio/broadcast ads, etc. In addition, the fellow will have an opportunity to work on projects within the Health Care Compliance organization. This would allow the fellow to develop an understanding of the importance of the Health Care Compliance program, industry codes, J&J HCC policies, and Federal and State laws as it relates to pharmaceutical companies' interactions with healthcare professionals (HCPs). Current Fellows Christine Bebawy, PharmD Olivia Calabro, PharmD St. John's University Temple University Second-Year Fellow First-Year Fellow Goals of the Regulatory Advertising and Promotion/ Healthcare Compliance Fellow Specific duties and goals include but are not limited to: 1) Interpret FDA regulations and guidance to ensure promotional communications and materials are properly addressed to HCPs and consumers 2) Develop knowledge and skills to provide appropriate HCC guidance to business partners to help foster a culture of business integrity and shared accountability 3) Strengthen various business and communication skills necessary to operate in a variety of positions across the pharmaceutical industry Preceptors Jia-Huey Huey, PharmD, RPh Director Regulatory Advertising and Promotion 25 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Office of the Chief Medical Officer (OCMO) Pharmacovigilance Fellowship Raritan, NJ and Skillman, NJ — 2 positions Fellowship Description This Office of the Chief Medical Officer (OCMO) Pharmacovigilance Fellowship is a two-year program that offers experience in a global safety environment of both the Pharmaceutical (Janssen) and Consumer Health sectors of Johnson & Johnson (J&J). The successful candidate will be exposed to an end-to-end pharmacovigilance experience including global case management, aggregate reporting, benefit-risk evaluations and risk management of adverse events, global marketing activity complaint management, safety vendor oversight, and audit and inspection readiness. Current Fellows Austin Morris, PharmD Daphne Liang, PharmD Hampton University Philadelphia College of Pharmacy First-Year Fellow First-Year Fellow Labasse Doumbia, PharmD Shameka Heber, PharmD Tom Pickens, PharmD Notre Dame of Maryland University Temple University Regis University First-Year Fellow First-Year Fellow Second-Year Fellow Katie Lee, PharmD Lilai Teum, PharmD St. John's University University of Maryland Eastern Shore Second-Year Fellow Second-Year Fellow 26 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Office of the Chief Medical Officer (OCMO) Pharmacovigilance Fellowship (cont’d) Raritan, NJ and Skillman, NJ — 2 positions Goals of the Office of the Chief Medical Officer Fellow Specific duties and goals include but are not limited to: 1) Support and understand the role of pharmacovigilance/product vigilance and safety surveillance processes within the functional groups of OCMO 2) Develop an understanding and working knowledge of overall pre- and post-marketing drug safety processes, analytical tools, and safety databases used in safety analyses 3) Support and gain experience in the management of Individual Case Safety Report (ICSR) collection and processing, including global pharmacovigilance requirements and related regulations, company policies and procedures, and internal business practices for all regulatory classes 4) Understand and participate in the evaluation of safety data for possible drug association to contribute to various regulatory medical safety documents as part of a multi-disciplinary team including Clinical, Toxicology, Regulatory Affairs, and Medical Affairs Preceptors Stefanie Emanuel, PharmD Director Global Case Management Office of Consumer Medical Safety Joseph Aquilina, MD, FACS Director Safety Surveillance & Risk Management Karen McLane, BSc, RPh Manager Central Pharmacovigilance Hub Martha Azer, PharmD, RPh Manager Case Processing Milind Amin, PharmD, RPh Operations Scientist Case Processing 27 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Non-Recruiting Fellowships 2021–2023 Global Consumer Health, Regulatory Affairs Strategy Medical Marketing Strategy, Cardiovascular Reema Chopra, PharmD Teresa Nguyen, PharmD Massachusetts College of Pharmacy and Health Sciences University of Texas at Austin Second-Year Fellow Second-Year Fellow Commercial Insights and Commercial Insights and Strategy–Oncology Strategy–Cardiovascular Waymond Zhou, PharmD Tiffany Chow, Richard Cericola, Taylor Hopwood, University of Illinois PharmD PharmD PharmD at Chicago Rutgers University Rutgers University University of Maryland First-Year Fellow Second-Year Fellow First-Year Fellow First-Year Fellow Medical Information & Global Competitive Intelligence, US Immunology Marketing, Knowledge Integration, Infectious Immunology Immunology Portfolio Solutions Diseases & Vaccines Hui Yi Tee, PharmD Isaac Warshawsky, PharmD Sonia Jacob, PharmD University of North Carolina at Chapel Hill Butler University Philadelphia College of Pharmacy First-Year Fellow First-Year Fellow First-Year Fellow US Oncology Franchise Marketing Global Medical Affairs, Oncology Bansi Dhaduk, PharmD Brandon Dang, PharmD Maksym Shysh, Pauline M. Kitolo, St. John's University PCOM Georgia PharmD PharmD First-Year Fellow First-Year Fellow Jefferson College University of Georgia of Pharmacy College of Pharmacy 28 First-Year Fellow First-Year Fellow J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
Former Fellow Testimonials “ I attribute much of my post-fellowship success to my enriching experience at J&J. The program enabled me to establish meaningful relationships with leaders across the enterprise and propelled my career in the pharmaceutical industry. As an alumna of the prestigious RPIF program, I have found that the unmatched network continues to serve Wanda M. Azu Owoh, PharmD, RPh me well as I grow in my profession. ” Associate Manager Regulatory Affairs “ My Janssen fellowship in Commercial Insights and Strategy provided me with valuable experience and development needed to launch my career on the commercial side of the pharmaceutical industry. In this fellowship I worked on multiple projects related to launching a new drug and received exciting exposure to different functional areas in the company. The fellowship was the perfect foundation to set me up for success as ” Mary Mettias, PharmD I transitioned into my commercial role. Product Director HCP Professional Promotions Cardiovascular “ The industry component at J&J coupled with the academic exposure at Rutgers allowed me to actively use my PharmD knowledge in both a teaching environment and a customer- focused business setting. The program is unique in its emphasis on providing a comprehensive program and a tremendous network that develops fellows into innovative thinkers. While many years have passed since I completed my fellowship, I remain connected to the program as alumna and mentor because I believe this program is valuable in building Nancy V. Nair, PharmD, MBA a deep bench of pharmacy leaders that will change the way Director Global Regulatory Affairs industry brings transformational medicines to patients. ” 29 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
RPIF Alumni at Janssen Over 40 Alumni fill positions across an array of departments Commercial Excellence Marketing Dhaval Patel (2018) Jake Bryant (2002) Manager, Market Research Group Product Director, Marketing Paul DiPietro (2018) Jannell DePalantino (2005) Manager, Market Research & Integrated Analytics National Director, Oncology Clinical Educator Team Todd Gilbert (2019) Mohamed Issa (2005) *Roche Fellowship Manager, Strategic Customer Intelligence Senior Director, Franchise Strategy Krista Allbee (2019) Sonal Chaudhari (2005) Manager, Market Research Senior Manager, Marketing Medical Devices Kinjal Patel (2020) Mike D’Uva (2013) Manager, Integrated Analytics Product Director, Customer Experience Alexa DeVita (2020) Manager, Specialty Mary Mettias (2013) Pharmacy & Patient Analytics Product Director, Professional Promotion Felix Vainer (2017) Research & Development Product Manager, Immunology Yu Mao (2018) Jalak Patel (2018) Associate Director, R&D Strategy and Operations Product Manager, Engagement and Education Erin McGuire (2018) Carolyn Riedl (2019) Senior Clinical Scientist Product Manager, Integrated Customer Solutions Anastasiya Koshkina (2020) Diana Destin (2019) Associate Director, Clinical Scientist Product Manager, Patient Experience Medical Information Regulatory Affairs Kristin Goettner (2004) Senior Director, Erin Wells (2002) Medical Information & Knowledge Integration Regulatory Compliance Lead Phung Quach (2004) Associate Director, Medical Nancy Nair (2003) Information & Knowledge Integration Director, NA Regulatory Lead Tejas Patel (2020) Sales/Sales Training Regulatory Compliance Lead Christina Warters (2017) Specialty Representative Medical Affairs Nishi Ghelani (2018) Nimisha Rathod Shah (2002) Key Account Specialist Scientific Field Director, Medical Science Liaison Dana Huettenmoser (2018) Ramona Haile (2008) Specialty Representative Associate Director, Medical Sciences Self Care Nick Spotts (2020) Dhaval Patel (2014) *Sanofi Fellowship Oncology Specialist Associate Director, Medical Alignment Benjamin LeMay (2020) Keith Fairall (2015) Specialty Representative Field Director, Medical Science Liaison Paul Cornelius (2020) Jessica Lewis (2018) Sales Trainer Senior Medical Science Liaison Business Development Allison Bisson (2018) Senior Medical Science Liaison Nancy Ondovik (1999) Wanda Azu Owoh (2019) Senior Director, Business Development and Licensing Medical Science Liaison Ankur Patel (2005) Heena Mavani (2019) *Novartis Fellowship Senior Counsel, Business Development Senior Medical Science Liaison Carly Herbert (2020) Medical Science Liaison 30 J&J Consumer Janssen Table of Introduction J&J, Inc. Non-Recruiting Former Fellow RPIF Health Pharmaceutical Contents Fellowships Fellowships Testimonials Program Fellowships Fellowships
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