The USC Pharmaceutical Industry Fellowship programs are designed to prepare postdoctoral scholars for rewarding careers in the pharmaceutical and biopharmaceutical industry. Fellows work with mentors to participate in activities that enhance the skills required to excel in their field. Selected graduate coursework in the regulatory sciences, biopharmaceutical marketing and health care decision analysis programs, among others, at the USC Mann School of Pharmacy and Pharmaceutical Sciences are part of the fellowship in addition to the training they receive at our industry partner sites.
Training opportunities available for doctoral candidates include the broad categories of clinical development, clinical pharmacology, drug delivery systems, immunology, medical affairs, pharmaceutical sciences, portfolio strategy and project management regulatory affairs, research pharmacology, toxicology, and others.
Please refer to the brochures below for specific programming offered with our various industry partners including 1.) AbbVie, Inc, 2.) Arcutis Biotherapeutics, Inc, 3.) Bristol-Myers Squibb, 4.) Gilead Sciences, 5.) Kite Pharma, 6.) MannKind Corporation, and 7.) Neurocrine Biosciences. Each of these fellowships offer unique opportunities for the trainees to gain specialized skill for their chosen field.
Upon completion of the program, fellows will be prepared for the challenges of a career in the pharmaceutical industry. Past fellows have been placed into rewarding positions in industry, pharmacy practice and research. All fellowships begin July 1 and end on June 30.
Key Highlights
- Access to USC Regulatory Science, Biopharmaceutical Marketing, and Health Care Decision Analysis courses, among others, with tuition remission up to four units per semester
- Opportunity to participate in various certificate programs at the USC Mann School
- Networking with USC students and alumni
- Participating in professional leadership workshops
- Financial relocation assistance for out-of-state fellows
- Financial support to attend professional conferences and events
- Participate in teaching opportunities at the USC Mann School
- Recruiting prospective graduate and professional students to the Fellowship Program
Available Fellowships
AbbVie, Inc.
The one-year Clinical Development Fellowship provides an immersive introduction to clinical research in global drug development. As an active member of multiple clinical teams, the fellow will develop an understanding of the principles and challenges of developing novel therapeutics, while operating within national and international guidelines for good clinical practice. With close guidance from mentors, the fellow will gain broad exposure to interdisciplinary functional areas, with latitude to set individualized objectives within projects of particular interest.
Objectives of the Clinical Development Fellow
- Explain Pharmacology of therapeutic agents developed at Abbvie, and their use in clinical setting
- Explain the operational aspects of designing and executing a clinical trial
- Formulate a research protocol for a novel therapeutic agent
- Explain the place in therapy of a medication within national and international guidelines for good clinical practice.
- Complete USC graduate coursework as applicable
This non-laboratory based one-year Clinical Pharmacology Fellowship focuses on developing skills of a modern clinical pharmacology scientist. The fellow will be provided opportunities to gain expertise in nonclinical and clinical development through honing skills in areas such as nonclinical pharmacokinetics/toxicokinetics, clinical pharmacology, translational strategies, modeling and simulation/pharmacometrics. As part of the training, the fellow will be provided with opportunities to engage in various activities such as: design and execution of nonclinical pharmacokinetic/toxicokinetic studies, design and execution of clinical pharmacology studies, development of translational strategies in support of target engagement and biomarker/ dose/regimen selection, preparation of regulatory documents, and PK/PD and pop-PK modeling. The candidate will also participate in cross-functional team interactions spanning all of AbbVie’s therapeutic areas. This advanced hands-on training program can be tailored towards the specific needs and background of the candidate.
Objectives
- Design and execute non-clinical (pharmacokinetic/toxicokinetic) or clinical pharmacology research studies.
- Draft regulatory documents related to therapeutic agents
- Present work at a professional meeting or author a scientific publication (if applicable)
- Complete USC graduate coursework as applicable
The one-year Drug Delivery Sciences Fellowship focuses on the design of new drug delivery systems and process development — including inventing new systems and exploring novel adaptations of existing systems. The fellowship is intended to give postdoctoral research graduates exposure to the pharmaceutical industry, while advancing the fellow’s research and professional growth. The program focuses on enhancing postdoctoral research training and providing an opportunity to integrate with various departments and disciplines within the pharmaceutical industry. Acting within an individualized plan, the fellow participates as a member of AbbVie, Inc.’s Drug Delivery Center of Excellence within Pharmaceutical Development.
Objectives of the Drug Delivery Sciences Fellow
- Design and evaluate drug delivery system for sustained release and targeted distribution to physiological sites
- Develop and evaluate new delivery systems based on polymers, emulsions or related areas
- Complete USC graduate coursework as applicable
The one-year Global Regulatory Affairs (GRA)-Strategy Fellowship provides fellows with an overview of Regulatory Affairs (RA) responsibilities, including application of regulations and health authority guidance to help develop regulatory strategies. The fellow will have hands-on experience developing the skills to prepare various global regulatory submission documents for products in drug development and life cycle management. The fellow is an active contributor of the Asset Strategy Team and shares the responsibility for facilitating timely submission of these documents to regulatory agencies worldwide. In addition, the fellow has the unique networking opportunity to manage several projects inside and outside of GRA as part of a comprehensive training program.
Objectives
- Explain regulatory strategies for drug development, clinical study planning, and US regulations
- Explain Food and Drug Administration (FDA), ICH guidelines and other Health Authority regulations for drug development
- Collaborate on and lead projects within global regulatory affairs office, which include assembly and management of regulatory documents for FDA and other Health Authorities (HA)
- Identify, and collaborate with key stakeholders for drug development such as Clinical Development, project management, research and development, toxicology, clinical pharmacokinetics, quality assurance and others.
- Collaborate on developing regulatory strategies for drug development, clinical study planning, and project implementation with Asset strategy team and regulatory affairs leadership
The one-year Immunology Fellowship mainly focuses on immunogenicity studies against biologics and toxins to support drug development programs. As part of the training, the fellow will be provided with opportunities to participate in various activities like designing experiments, executing experiments and data analysis. It also involves cross functional team interactions across multiple therapeutic areas within AbbVie. Additionally, interested fellows can gain expertise in flowcytometry, Luminex, ex vivo/in vivo assays. The fellowship is intended to enhance the postdoctoral research training of the applicant and develop the skills required to excel in their field.
Objectives
- Review and analyze immunogenicity data for internal ophthalmology, toxin and device programs
- Analyze data from literature about in silico and in vitro assays
- Perform in vivo/ex vitro assays to investigate potential benefit and risk evaluation for devices.
- Complete USC graduate coursework as applicable
The one-year Medical Affairs Fellowship focuses on providing exposure to three pillars of functionality: medical information, global Phase IV trials and external scientific communications. The fellow will have firsthand experiences in medical information database operations, post-marketing clinical research management and global strategic publication planning. Fellows will gain the necessary tools to become successful professionals within the pharmaceutical industry, as well as the opportunity to network with AbbVie, Inc. fellowship alumni.
Objectives of the Medical Affairs Fellow
- Provide transparency regarding clinical trial issues
- Partner with internal and external global stakeholders to plan and disseminate Abbvie’s scientific data through high quality and medically relevant publications
- Provide information to medical science liaison teams
- Complete USC graduate coursework as applicable
The one-year Pharmaceutical Sciences Fellowship focuses on the design and evaluation of novel ophthalmic and dermal formulations. The fellow will have opportunities to gain firsthand experience within various functional areas of pharmaceutical product development.
Objectives of the Pharmaceutical Sciences Fellow
- Design and analyze novel ophthalmic and dermal formulations
- Evaluate the effect of excipients and processing parameters on quality and performance
- Review and analyze new formulation platform technologies
- Write protocols and technical reports
- Complete USC graduate coursework as applicable
This one-year Research Pharmacology Fellowship focuses on developing the pre-clinical translational skills required of a pharmacology scientist. As part of the training program, the fellow will participate in pre-clinical study activities including study conceptualization through study design, protocol development, study execution, and cross functional team interactions across multiple therapeutic areas within AbbVie. Additionally, interested fellows can gain expertise in pharmacology sections of regulatory submissions, and interact with scientists from other functions such as formulation development, clinical pharmacology and clinical development. The fellowship is intended to enhance the postdoctoral research training of the applicant with hands-on application of core biological principles and techniques to move programs from preclinical stages to clinical development for key AbbVie programs.
Objectives
- Design and conduct pharmacology pre-clinical research projects
- Participate in regulatory submission of pre-clinical trials (if applicable)
- Analyze pre-clinical research results and formulate it into reports
- Present reports at professional meetings or as scientific publication (if applicable)
- Complete USC graduate coursework as applicable
The one-year Toxicology Fellowship focuses on developing the skills needed to identify the toxicology and safety pharmacology studies required to support drug development programs, to independently design toxicology studies and to be able to interpret and integrate data from toxicology studies into risk assessments in support of product safety and dose selection for initiating clinical investigations or regulatory submissions. As part of the training, the fellow will engage as Toxicology Representative on project teams, prepare regulatory documents, learn about the assessment of testing facilities and participate in cross-functional team interactions.
Objectives
- Explain requirements of non-clinical safety testing of pharmaceutical drugs to support conduct of clinical trials and marketing authorization
- Explain, design and execute toxicology and non-clinical safety studies
- Explain global regulatory agency functions
- Provide advice as toxicology representative on projects to guide non clinical safety strategies
- Complete USC graduate coursework as applicable
Arcutis Biotherapeutics, Inc.
Arcutis Biotherapeutics, Inc. is a medical dermatology company that champions meaningful innovation to solve most persistent challenges of patients with immune-mediated dermatological diseases and conditions. During this program, the fellow will experience different roles within the medical affairs department. This includes medical communications, field medical, operations and medical information. This fellowship program will provide an opportunity to learn the necessary skills to excel in a pharmaceutical industry. During this program, the fellows can be provided with an opportunity to rotate in different departments to gain comprehensive experience based on their interest and time availability.
The learning objectives for this program are:
- Deliver accurate, scientifically balanced, and evidence-based information to healthcare providers and patients
- Create, and update key resources used by internal and external stakeholders to communicate disease state information, and data on Arcutis products
- Support the medical team through training and strategies that are aligned with key opinion leader priorities
- Participate in and/or lead medical affairs projects
- Complete USC graduate coursework as applicable
Bristol-Myers Squibb Company
The USC-BMS Regulatory Science Onsite HEOR Fellowship in RWE is a two-year postdoctoral fellowship program designed to combine experiential training onsite at BMS with academic education in regulatory science at USC, specifically focusing on healthcare & regulatory policy, including the use of real-world data to generate real-world evidence for healthcare & regulatory policy and decision making. The selected postdoctoral fellow will pursue a graduate education in Master’s in Regulatory Management as a distance student while conducting research and hands-on experiential training onsite at BMS. Upon completion of the fellowship, the individual would be ready to advance the use of RWD and RWE to accelerate the availability of, and patient access to, new therapies.
The USC Master of Science in Regulatory Management program is designed to provide post-doctoral scientists and clinicians with the knowledge and skills necessary to become proficient in regulatory and clinical research. The graduates of this program will be knowledgeable in regulatory strategic planning for product development and commercialization, including the design and evaluation of interventional and non-interventional clinical research. The onsite HEOR experiential component is designed to provide the fellow with the HEOR technical skills, data generation, data dissemination and professional development in a real-world setting. This interdisciplinary curriculum will provide fellows with advanced training in regulatory and HEOR. The academic components are offered on weekends and can be accessed remotely to accommodate working professionals.
Gilead Sciences, Inc.
The USC Mann School and Gilead Sciences, Inc. are proud to offer two 2-year Oncology Clinical Development fellowship positions designed to provide recent doctoral graduates (PharmD, MD, DO, PhD, or equivalent doctorate degree) graduates an opportunity to learn the skills and experiences to excel in Clinical Development within Gilead’s Clinical Development Oncology Department. The fellowships are based at the Gilead U.S. headquarters in Foster City, California and include opportunities to rotate through other departments at Gilead. The fellows will be an integral part of the Clinical Development Oncology Department and partake in core clinical development activities within individual study management teams, as well as internal and external stakeholder management.
Clinical Development, Oncology Fellowship Activities:
Develop understanding of assigned program and molecule within the company pipeline:
- Review of literature and scientific materials, as well as contribute to the clinical development plan. Opportunity to be involved in study design and study start up activities
Clinical Development strategy
- Potential to contribute to the clinical development plan for the assigned program or molecule
Author and maintain key clinical documents:
- Participate in the development of study protocol (publication and amendments), informed consent forms, medical monitoring plan, and relevant publication plan
Medical Monitoring:
- Participate and lead medical monitoring activities to ensure study conduct integrity which involve activities that include but not limited to: responding to study eligibility inquiries, perform medical data review, manage medical resolutions with investigators as needed
Scientific communication and stakeholder management:
- Participate and present at investigator meetings, site initiation visits, KOL engagement, and study steering committee interactions
Fellowship Recruitment:
- Participate and lead fellowship recruitment activities at regional and national conferences
USC Graduate Coursework:
- Complete required graduate coursework at the University of Southern California with the opportunity to complete a Graduate Certificate Program in a variety of fields
Leadership, and Career Development:
- Participate in the University of Southern California, School of pharmacy Professional Development and leadership Retreat.
The Oncology Global Medical Affairs Fellowship, offered in collaboration with the University of Southern California and Gilead Sciences, is designed for a doctoral-level graduate (PharmD, MD, or PhD) interested in pursuing a career in the pharmaceutical industry. The fellow will have extensive exposure to the Global Medical Affairs organization and gain a thorough understanding of the role of Medical Affairs within the oncology pharmaceutical industry.
Global Medical Affairs – Oncology Fellowship Activities:
Oncology Medical Affairs External-Sponsored Research:
- Manage projects related to the review, approval, and medical oversight of the Oncology Medical Affairs collaborative studies research program
Strategic Planning:
- Help with project management of the Global Medical Affairs Plan of Action (POA) and Integrated Evidence Plan (IEP), strategic workshops, and Global Medical training
Medical Affairs Launch Activities:
- The fellow will have the opportunity to review promotional materials, commercial learning and development materials, and Medical Information generated response documents to ensure medical accuracy, alignment with product indication, and alignment with the Medical Affairs Plan of Action and strategic messaging
Operational Excellence:
- Collaborate with the Global Medical Affairs team to work on projects regarding process improvement and implementation of new technology
Compliance:
- Learn and comply with regulations and guidance from the various national and global regulatory agencies that govern the pharmaceutical industry.
Collaboration:
- Collaborate with colleagues from other departments to learn about the role of Global Medical Affairs in the wider organization
External-Department Rotations:
- Based on the fellow’s interests, there is an opportunity to participate in rotations with external departments to gain a comprehensive experience and skills in pharmaceutical industry
- Potential departments to perform a rotation with may include Affiliate Medical Affairs, Field-Based Medical Sciences, Regulatory Affairs, Marketing, etc.
USC Graduate Coursework:
- Complete graduate coursework at the University of Southern California with the opportunity to complete a Graduate Certificate Program in a variety of fields
Leadership, Teaching and Career Development:
- Participate in USC Mann Professional Development and Leadership Retreat and precept Advanced Pharmacy Practice Experience (APPE) rotation students
The USC Mann School and Gilead Sciences, Inc. are proud to offer a 12-month Global Medical Affairs Learning and Development (L&D) Fellowship Program designed to provide recent PharmD, MD and PhD graduates an opportunity to learn the skills necessary to excel in a career in the pharmaceutical industry by working within the Global Medical Affairs Learning & Development function while also supporting other teams within the Global Medical Strategic Operations (GMSO) organization.
Learning and Development Fellowship Activities
- Learning & Development:
Design, develop, and coordinate the delivery of Global and U.S. Medical Affairs learning events and content, eLearning, eBooks, slide decks, and videos - Cross-Functional Collaboration:
Collaborate with colleagues across Global Medical Strategic Operations (GMSO) and the broader Medical Affairs organization, including Medical Engagement Center of Excellence, Scientific Communications Center of Excellence, Medical Affairs operations, Medical Education & Programs, External Medical Affairs, Strategic Planning, and Medical Insights, as well as Global and Regional Therapeutic Area teams - Operational Excellence:
Work on projects with the Global L&D team related to process improvement, development and implementation of new operational systems - Collaboration:
Collaborate with colleagues from other departments to learn about the role of Medical Affairs in the wider organization - USC Graduate Coursework:
Complete required graduate coursework at USC with the opportunity to complete a Graduate Certificate Program in a variety of fields - Compliance:
Learn and comply with regulations and guidance from various national and global regulatory agencies that govern the pharmaceutical industry - External-Department Rotations:
Based on the fellow’s interests, there is an opportunity to participate in rotations with external departments across the Gilead organization to gain a comprehensive experience and diverse skillset in the pharmaceutical industry - Leadership, Teaching and Career Development:
Participate in the USC Mann School Professional Development and Leadership Retreat
The USC Mann School and Gilead Sciences, Inc. are proud to offer two 12-month Medical Information Fellowships designed to provide recent PharmD graduates an opportunity to learn the skills and experiences to excel in Medical Information, a key function in any Medical Affairs organization across the pharmaceutical industry. The fellowships are based at the Gilead U.S. headquarters in Foster City, California. The Fellows will be integral to the Global and U.S. Medical Information teams that develop and manage Medical Information content in response to requests from healthcare professionals, patients, and their caregivers.
Objectives
- Create and review medical information content for healthcare providers and patients
- Develop scientifically balanced responses in certain therapeutic fields to Gilead Medical Resource Center
- Implement new technologies to support medical information and support inspection readiness
- Provide drug information
- Explain and comply with regulatory laws that govern pharmaceutical industry
- Complete USC graduate coursework as applicable
Medical Information Fellowship Activities:
Medical Information Content:
- Write, update and review Medical Information content for healthcare providers and patients such as Global Response Documents (GRDs), Local Response Documents (LRDs), Patient Response Documents (PRDs), and alternative content formats (including infographics)
Medical Information Clinical Expertise:
- Work with the Global and U.S. Medical Information Clinicians to develop clinical expertise in specific therapeutic areas in order to draft and disseminate unbiased and scientifically balanced responses to requests for medical information escalated from the Gilead Medical Resource Center (GMRC)
Operational Excellence:
- Work with Medical Information and Operations teams across regions on process improvement initiatives, implement new technologies to support Medical Information, ensure inspection readiness, and help manage the GMRC
Cross-Functional Collaboration:
- Collaborate with colleagues from other departments (Commercial, Marketing, Medical Scientists, etc.)and support Medical Affairs by providing product and drug information expertise on a wide range of initiatives including staffing the medical information booth at national scientific meetings and consulting on cross-functional activities
Compliance:
- Learn and comply with regulations and guidance from various national and global regulatory agencies that govern the pharmaceutical industry
External-Department Rotations:
- Based on the Fellow’s interests, there is an opportunity to participate in rotations with external departments across the Gilead organization to gain a comprehensive experience and skillset in the pharmaceutical industry
- Potential departments to perform rotations with include: Regulatory Affairs (Advertising and Promotion), Field-Based Medical Sciences, Medical Affairs Research (Phase IV/Investigator Sponsored Research), etc.
USC Graduate Coursework:
- Complete required graduate coursework at the University of Southern California with the opportunity to complete a Graduate Certificate Program in a variety of fields
Leadership, Teaching and Career Development:
- Participate in the USC Mann School Professional Development and Leadership Retreat and precept Advanced Pharmacy Practice Experience (APPE) rotation students
The USC Mann School and Gilead Sciences, Inc. are proud to offer two 2-year Patient Safety Fellowship positions for two recent doctoral graduates (PharmD, MD, PhD, or equivalent doctorate degree). Patient Safety is a crucial part of drug development and commercialization to predict, mitigate, manage and communicate the risks of Gilead’s medicines, so patients can derive the maximum benefit. The Patient Safety (PS) fellowship will be located at our Foster City, CA, campus, and two fellows will be chosen to work with our PS team. There will be occasional travel as required for in-person conferences and meetings. The fellow will be integral to the PS team and will work closely with our PS Scientists and Physicians and Global Safety Leads.
Patient Safety Fellowship Activities
Pharmacovigilance:
- Learn about U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations related to pharmacovigilance practices including:
- Regulations related to the reporting of Adverse Events
- The preparation of aggregate safety reports such as Development Safety Update Reports (DSUR) and PBRER (Periodic Benefit Risk Evaluation Report)
- The development and maintenance of risk management plans (RMPs)
- Observe how individual case safety reports are evaluated
- Support implementation of decisions from the signal evaluation process, including updates to core safety information, Investigator’s Brochure, and other key safety documents.
- Conduct signal detection and evaluation activities for assigned products in collaboration with the Patient Safety Physician and Scientist as part of the continuous benefit-risk evaluation throughout the product lifecycle.
- Contribute to safety reviews of adverse events, including learning to evaluate adverse events using various analytical tools and data sources.
- Contribute to activities related to regulatory filings, New Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from regulatory agencies.
- The fellow may work in a combination of therapeutic areas including oncology, virology, or inflammatory diseases.
- Exposure to other areas of safety including safety operations, analytics, and coding may be offered if interested
Safety in Clinical Trials:
- Support the review of clinical trial protocols, Investigator’s Brochures, and clinical study reports.
- Contribute to the preparation of informed consent forms.
- Support the review and monitoring of clinical trial safety data.
- Collaborate with Patient Safety Operations colleagues to ensure safety reporting issues are addressed.
Cross-Functional Collaboration:
- The fellow will have an opportunity to collaborate with colleagues from other departments such as Regulatory Affairs, Clinical Development, Medical Affairs, Clinical Pharmacology, and Nonclinical Safety & Pathobiology to learn about how these functions interact with PS.
USC Graduate Coursework:
- Complete required graduate coursework at USC with the opportunity to complete a Graduate Certificate Program in a variety of fields.
Leadership and Career Development:
- Participate in the USC Mann School Professional Development and Leadership Retreat.
The USC-Gilead Sciences HIV Prevention Medical Affairs Fellowship program will provide an opportunity for a recent PharmD graduate to learn the skills necessary to excel in a career in the pharmaceutical industry and Medical Affairs, focusing on Gilead’s HIV Prevention strategy.
Objectives
- Create and review the medical content for the Medical Affairs HIV prevention Plan of Action (POA)
- Analyze promotional materials and medical information generated response
- Explain and comply with regulatory laws that govern pharmaceutical industry
- Complete USC graduate coursework as applicable
Medical Affairs – HIV Prevention Fellowship Activities:
Develop Strategy Thinking:
- The fellow will be involved in the creation and review of the Medical Affairs HIV Prevention Plan of Action (POA) and help ensure medical content, messaging, and reactive tools support execution of the POA
Medical Affairs Content:
- The fellow will be involved with the creation, updating, and review of Medical Affairs content such as reactive slide decks, FAQ documents, Medical Affairs advisory presentations, and Commercial Learning and Development Presentations
Participate in Medical Review:
- The fellow will have the opportunity to review promotional materials, commercial learning and development materials, and Medical Information generated response documents to ensure medical accuracy, alignment with product indication, and alignment with the Medical Affairs Plan of Action and strategic messaging
Cross-Functional Collaboration:
- The fellow will collaborate and teamwork with colleagues from other departments to learn about the role of Medical Affairs in the wider organization.
Compliance:
- The fellow will learn and comply with regulations and guidance from the various national and global regulatory agencies that govern the pharmaceutical industry.
Additional Activities:
- Based on the fellow’s interest, there is an opportunity to participate in rotations with external departments to gain a comprehensive experience and skills in the pharmaceutical industry.
USC Graduate Coursework:
- Complete required graduate coursework at the University of Southern California with the opportunity to complete a Graduate Certificate Program in a variety of fields
Leadership and Career Development:
- Participate in the USC Mann School Professional Development and Leadership Retreat
Kite Pharma
Fellowship Overview
The USC Mann School and Kite, a Gilead Company, are proud to offer a 12-month Medical Information/Scientific Communications Fellowship program designed to provide recent Pharm.D., M.D., Ph.D. or equivalent advanced degree graduates an opportunity to learn the skills and experiences to excel in Medical Information and Scientific Communications, key functions in any Medical Affairs organization across the pharmaceutical industry. The fellow will be an integral part of the Global Medical Affairs team and will develop/manage scientific content and respond to requests for medical information about Kite products.
Fellowship Goal
To provide an opportunity for the fellow to learn the skills necessary for a successful career in the pharmaceutical industry with an emphasis in Medical Information and Scientific Communications.
Medical Information/Scientific Communications Fellowship Primary Objectives
- Create and review medical information content such as response letters, FAQ AMCP dossier, etc
- Formulate unbiased response to requests from medical information that has been escalated.
- Create high impact scientific and medical tools for the medical science field teams, scientific presentations, booth materials at conferences and scientific advisory boards
- Collaborate with the communications team on projects for process improvement and or development, managing call center, and implementation of new technologies
- Explain and comply with regulatory laws that govern pharmaceutical industry
- Complete USC graduate coursework as applicable
- Subject Matter Expertise
Participate in cell therapy training, with the goal of becoming a subject matter expert throughout the course of the fellowship. Attend scientific meetings to maintain that expertise, participate in session coverage, and staff the Medical Affairs booth.
- Medical Information Content
Write, update, and review Medical Information content such as standard response letters (SRLs), frequently asked questions (FAQ) documents, and slide decks (if applicable). In addition, the fellow may assist in the creation or maintenance of an AMCP dossier and compendia submissions.
- Respond to Unsolicited Requests for Medical Information
Coordinate with the Medical Information specialists at Kite’s call center to formulate unbiased and scientifically balanced responses to requests for medical information that have been escalated. Escalated requests will be proposed by the fellow and reviewed by the appropriate subject matter experts prior to fulfillment by the call center.
- Scientific Communications Content
Create high-impact scientific and medical tools for the medical science field teams, medical affairs scientific presentations, scientific booth materials at key congresses, and content at scientific advisory boards.
- Medical Review
Function as a medical reviewer for Promotional Review Committee, Medical Review Committee, and for Commercial Learning and Development pieces.
- Operational Excellence
Work with the Kite Medical Information and Scientific Communications teams on projects regarding process improvement/development, implementation of new technology, and managing the call center.
- Collaboration
Collaborate with other departments at Kite to learn the value that Kite Medical Information and Scientific Communications bring to the broader organization.
- Compliance
Learn and comply with regulations and guidance from various national and global regulatory agencies that govern the pharmaceutical industry.
- Rotations with External Departments
Opportunities to participate in rotations with external departments across the Kite organization including Regulatory Affairs (Advertising and Promotion), Field-based Medical Affairs, Marketing, etc. to gain a comprehensive experience and skill set in the pharmaceutical industry.
- USC Graduate Coursework
Complete required graduate coursework at USC with the opportunity to complete a Certificate in Regulatory Sciences or Healthcare Decision Analysis.
- Leadership, Teaching and Career Development
Participate in teaching opportunities at USC through collaborations with the USC Mann School and gain guidance on career advancement at the annual Professional Development and Leadership Retreat.
MannKind Corporation
In collaboration with the USC Mann School, MannKind Corporation’s Global Headquarters in Westlake Village, California is proud to offer a one-year Medical Affairs Post-Doctoral Fellowship from July 1, 2022 to June 30, 2023. There are two fellowship positions that will be offered to motivated and high-performing PharmD fellowship candidates for the 2022 Fellowship Class.
As an integral member of Mannkind’s Medical Team, the fellow will gain exposure and get hands-on practice experience in the Medical Affairs functional specialty in the biopharmaceutical industry. These will include developing, participating, and being an integral team member on business priorities including:
- Headquarters Medical Information and Vendor Management
- Field-based external Medical Communications (ie, collaboration with Medical Science Liaisons)
- Medical Congress Planning and Attendance
- Publication Planning
- Advisory Board Development
- Investigator-Initiated Trials
- Phase 1-4 Studies (ie, design, development, implementation)
- Exposure and collaboration with various internal departments (Clinical Development, Regulatory Affairs, Pharmacovigilance, Marketing, Sales/Sales Training, Business Development, etc.
Fellows will have many opportunities to travel to Medical Conferences (based on COVID guidelines) and work on project teams to develop and refine leadership, communication, decision-making, interpersonal, and influence skills.
Training objectives of the fellowship will include:
- Create and deliver scientifically balanced medical information to healthcare professionals
- Create and review scientific communication materials for internal and external communication
- Review commercial materials with other departments
- Collaborate with safety surveillance teams to capture insights to present to the broader medical and clinical affairs organization
- Explain international regulatory rules (outside US)
- Complete USC graduate coursework as applicable
Neurocrine Biosciences
The two-year Field Medical Affairs/Medical Science Liaison (MSL) Fellowship is designed to provide the trainee with a comprehensive understanding of the MSL role and insight into the various roles within Medical Affairs. The fellowship will provide training activities that support company goals as well as developmental opportunities through broad-based hands-on experiences and mentorships that integrate them into several Medical Affairs strategic initiatives. Upon completion of the program, the Fellow will be better prepared for the challenges of an MSL career in the pharmaceutical industry.
Fellowship Objectives
- Participate in MSL certification and presentation skill development
- Support the team through providing scientific information aligned with key opinion leader (KOL) priorities
- Assist in creating evidence based balanced information about Neurocrine approved and pipeline products to internal stakeholders and external customers
- Support product speakers’ bureaus with required medical information
- Participate in site nominations, study initiation visits, data dissemination and Investigator Initiated Trial Process (IIT)
- Develop a longitudinal research project
- Mentor pharmacy students and first year fellow
- Complete USC graduate coursework as applicable
The one-year Medical Communications Fellowship is designed to provide the trainee a broad understanding of the various roles and responsibilities within Medical Affairs. The fellowship will provide training activities that support company goals; as well as developmental opportunities through broad-based hands-on experiences and mentorships that integrate them into several medical strategic initiatives. Upon completion of the program, the Fellow will be better prepared for the challenges of a Medical Communications career in the pharmaceutical industry.
Fellowship Objectives
- Deliver accurate, scientifically balanced and evidence-based information to healthcare providers and patients
- Create, and update key resources used by internal and external stakeholders to communicate disease state information, and data on Neurocrine approved and pipeline products
- Assist in the execution of strategic publication plans
- Support the development of educational materials based on Neurocrine therapies and disease states
- Support the medical team through training and strategies that are aligned with key opinion leader priorities
- Develop longitudinal research project
- Mentor pharmacy students
- Complete USC graduate coursework as applicable
The one-year Regulatory Affairs (RA) Fellowship is designed to provide a broad understanding of the various roles and responsibilities within Regulatory Affairs including Strategy, Chemistry Manufacturing and Control, Advertising and Promotion, Labeling, and Publishing as well as having the opportunity to work on projects in other cross-functional departments such as Quality Assurance, Project Management, and Medical Writing.
The Fellowship will provide hands-on training, experience and mentorship while working with cross-functional partners on Neurocrine developmental programs. The fellow will play a key role in facilitating timely submission of documents to regulatory agencies. In addition, the fellow will have opportunities to work on several projects inside and outside of RA in collaboration with other departments as part of a comprehensive training program.
Upon completion of the program, the fellow will understand the various Regulatory Affairs functions and interactions with key cross-functional partners.
Fellowship Objectives
- Review scientific documents supporting regulatory filings and match it with current regulations and guidelines
- Explain drug development procedure and product approval
- Design, complete and present a longitudinal research project
- Mentor pharmacy students
- Complete USC graduate coursework (as applicable)
USC
The one-year Academic Pharmacy Fellowship is designed to train future faculty members to become national leaders in addressing the global deficit in health professions education and training in digital health. Fellows will be able to develop pharmacy education to include the development of digital health skills at their respective academic institutions. Additionally, the fellow will be able to create digital health awareness and training to be included in residency programs and teaching certificate programs, to ensure digital literacy of our future pharmacy practitioners and educators. As evidenced by the rapid move to the virtual delivery of healthcare services precipitated by the COVID-19 pandemic, it is expected demand for clinical faculty members with this specialized skill set will continue to grow.
Objectives of the Academic Pharmacy Fellowship Program
Upon completion of this fellowship, the learner should be able to do the following:
- Develop and implement projects related to digital health in pharmacy education and training programs
- Use the Kirkpatrick Model to design evaluation tools to assess and evaluate learner outcomes as the result of curricula and educational interventions
- Disseminate results of scholarship of teaching projects via presentations and peer-reviewed abstracts and manuscripts
- Design and coordinate a course within a Doctor of Pharmacy program
- Incorporate evidence-based instructional methods in the delivery of educational interventions for student pharmacists and other trainees
- Identify key elements of the academic environment and faculty roles within it
- Complete USC graduate coursework as applicable
Training and Graduate Coursework
- The Academic Pharmacy Fellow will complete graduate coursework during the fellowship including Principles of Biostatistics (PM510) and selected courses from Academic Medicine tailored to the fellow’s background and interest that can lead to a Certificate in Academic Medicine.
- Sample coursework can include ACMD 511 Competencies in Academic Medicine and Health I, ACMD 512 Competencies in Academic Medicine and Health II, ACMD 513 Professionalism in Academic Medicine and Health, and ACMD 514 Accreditation and Program Evaluation in Academic Medicine.
- Please see website for courses in the Academic Medicine program. Certificate in Academic Medicine | Academic Medicine Program (usc.edu).
- Professional meetings, workshops, other coursework and training specific to digital health will be provided throughout the fellowship training as these opportunities become available.
The two-year Clinical Translational Sciences Fellowship provides the framework for the fellow to gain skills in bridging clinical and basic sciences research under the guidance of mentors and the resources of USC Mann. The goal is to develop practitioners with skills for positions in academia and/or pharmaceutical industry with an emphasis in translational research.
Objectives of the Clinical Translational Sciences Fellow
- Train clinical scientists in clinical and or translational research through didactic and experiential instruction
- Train practitioners in a subspecialty of clinical practice with the research skill sets to advance evidence-based practice. Depending on the candidate, subspecialty areas can include cardiology, genomics, infectious diseases, psychiatry, among others
- Complete graduate coursework to develop research skills as it relates to the research
- Complete research for presentation at national scientific meetings and for publication in the appropriate scientific journal
- Submit for grants at the appropriate organizations related to further research