One Health Plaza, East Hanover, NJ 07936
Fellowship Positions Available
- Clinical Research and Development (Phase II-III)
- Early Clinical Development/Translational Medicine (Phase I-II)
- Regulatory Affairs
- Oncology Scientific Communication
- Oncology Medical Information/Field Medical Strategy
- Medical Information / Regulatory Affairs Advertising and Promotion
- Commercial - Marketing/Business Development & Licensing (BD&L)
- Field Medical
Novartis is a world leader in pharmaceutical research and development with over 123,000 employees of 142 nationalities around the world. In the United States alone, Novartis markets over 50 key products which helped the company achieve global sales of $48.5 billion. In 2016, Novartis had 16 major pharmaceutical approvals and 24 major submissions in the United States and Europe. The company has one of the industry’s strongest pharmaceutical pipelines providing novel medicines with over 50 marketed products and 200 projects in clinical development. Novartis Pharmaceuticals, headquartered in East Hanover, New Jersey, creates innovative medicines focused on enhancing lives through the treatment and prevention of diseases, shown through a portfolio with many leading products in Cardiology, Dermatology, Immunology, Neuroscience, Oncology, Ophthalmology, and Respiratory. The company’s dedication to research and development is supported by $9.0 billion annual global R&D investment, which enables it to assemble cutting-edge teams of experts from many fields who collaborate with the world’s renowned research centers.
The two-year Pharmaceutical Industry Fellowships at Novartis are designed to train and develop pharmacists across various disciplines within the pharmaceutical industry. Fellowship opportunities during the first year of the program are typically offered in the departments listed below, with the option to complete the second year of the program in a different department or discipline:
Position Detailed Descriptions
Clinical Research and Development (Phase II-III)
- Supports the conduct of global Phase II and III clinical trials with study startup, execution, or closeout activities.
- Collaborates with the Global Trial Director to coordinate activities with the Global Clinical Trials Teams to ensure goals are met for study timeline, budget, operational procedures, and quality standards.
- Assists the Global Trial Director with the development of study documents such as protocols, case report forms, and clinical study reports.
- Interacts regularly with all members of the global clinical development teams and with other Novartis line functions (such as Drug Regulatory Affairs, Biostatistics, Data Management, Programming, Medical Writing, and Drug Supply Management) as a participant in the Global Clinical Trial Team.
Early Clinical Development/Translational Medicine (Phase I-II)
Translational Medicine (TM) is a global, scientifically focused group which operates under the research arm of Novartis: the Novartis Institutes for BioMedical Research (NIBR). Scientists and clinicians within TM Clinical Sciences & Innovation (TM CS&I) and Translational Clinical Oncology (TCO) are primarily responsible for designing and conducting early phase clinical trials in healthy volunteers and patients. These trials explore and define the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and initial efficacy of small molecules, biologics, or cell-based therapies across numerous therapeutic areas, including oncology.
Fellowship opportunities are being offered in both TM CS&I (general and specialty medicine) and TCO (oncology). During their two-year fellowship:
- Fellows will be trained as a Clinical Trial Leader, coordinating all aspects of a clinical trial, which includes: writing clinical study protocol(s), designing case report forms (CRFs) and informed consent documents, selecting and initiating clinical sites, leading a clinical trial team, conducting investigator meetings, reviewing safety data, conducting dose escalation meetings, reporting and interpreting study results, as well as managing study timelines, drug supply, and study vendors.
- Fellows may also contribute to program-level activities, including the development of regulatory documents such as the Investigator’s Brochure, briefing documents, annual safety reports, regulatory submission documents, study abstracts, posters, and meeting presentations.
- Fellows may have the opportunity to support or conduct one or more: first-in-human, proof-of-concept, dose-range finding, PK drug-interaction, and/or mechanistic profiling studies for novel therapeutics.
- Serve as the primary liaison between Novartis and Health Authorities worldwide (e.g., the U.S. Food and Drug Administration) for regulatory activities and submissions.
- Provide strategic input and tactical support to expedite the development, submission, and regulatory approval of new drug or biologic products.
- Submit and maintain Investigational New Drugs (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Clinical Trial Applications (CTAs), and Marketing Authorization Applications (MAAs).
- Develop labeling strategy and lead team in negotiating and maintaining competitive labeling with Health Authorities worldwide.
- Review advertising and promotional materials to ensure compliance with applicable laws, regulations, and guidelines.
- Support life-cycle management activities post-approval.
Oncology Scientific Communication
Oncology Scientific Communication is responsible for developing and disseminating scientific information on Novartis products through publications, medical education, and medical expert management.
- In this role, the fellow will have the opportunity to develop and execute the global publication plan and medical education curriculum. The fellow will be responsible for the accuracy and quality of scientific content of manuscripts, abstracts, posters and presentations of clinical data. In additional, the fellow will develop internal medical communications and training.
Oncology Medical Information/Field Medical Strategy
Oncology Medical Information/Field Medical Strategy is responsible for using this scientific information to develop medical literature and drug information databases to research, evaluate, and develop evidence-based medical content for use by countries and regions to manage healthcare professional and customer interactions. Novartis offers a variety of Medical Information fellowships.
- In this role, the fellow will have the opportunity to develop high-quality (relevant, rigorous, balanced) medical information documents for healthcare customers in response to unsolicited inquiries about Novartis products.
Medical Information / Regulatory Affairs Advertising and Promotion
Regulatory Advertising and Promotion (A&P) is responsible for ensuring company communications promoting its products are consistent with laws and regulations which govern the promotion of prescription drugs in the US, as well as company policies and procedures related to these activities.
- In this role, the fellow will learn about the concepts and principles which inform US prescription drug promotional rules. In addition, the fellow will meet with multi-disciplinary teams who review proposed promotional materials, and will have the opportunity to provide regulatory guidance and inform business strategy on proposed promotional materials. The fellow will also review scientific, non-promotional materials for use by medical affairs associates.
- In a unique role, the fellow will complete one year in Regulatory A&P, and one year in Medical Information and Communications
Commercial - Marketing/Business Development & Licensing (BD&L)
The fellow works in cross functional disease area or brand teams that drive US Pharma strategy and growth. The primary objective is to deliver commercially meaningful brands to the US, providing recommendations to maximize US market opportunities including shaping Phase II and Phase III development programs, optimizing product profiles for successful launch and delivering on brand strategies to drive growth of Novartis promoted products.
Roles and responsibilities of the fellow include:
- Drive development of pipeline products through deliverables including situation analysis, options assessment, patient journey, target product profile, forecast and launch readiness plans.
- Participate in evaluation of business development & licensing opportunities, including scientific/clinical and commercial assessments and participate in due diligence of select opportunities.
- Develop, implement, and execute brand strategy, marketing mix and operational plans that optimize sales, market share and revenue growth for the short and long term.
Field Medical personnel are responsible for establishing and maintaining relationships with healthcare professionals by engaging in scientific discussions regarding Novartis products, therapeutic areas of interest, and sponsored research. Novartis offers two unique Field Medical related fellowships:
- In US Field Medical, the fellow will have the opportunity to develop internal medical resources and conduct field medical training for the US field medical team. During the second year of the program, the fellow will be assigned a territory to engage healthcare professionals in the field.
- In the Global Field Medical role, the fellow will have the opportunity to develop global field medical strategy, develop field medical resources, create internal global communications and conduct internal training.