COURSE CURRICULUM

The Master of Health Science (MHS) program at Fairleigh Dickinson University is designed to train students for advanced professional roles in clinical research administration and regulatory science, addressing the growing demand for highly skilled professionals in the pharmaceutical, biotechnology, and healthcare industries. The program begins with a shared core curriculum that builds essential competencies in public health and healthcare systems, including Fundamentals of Epidemiology, Introduction to Biostatistics and Data Analysis, Project Management, Ethics of Health Care Research, and Health Care Systems and Policy, providing students with a strong foundation in evidence-based healthcare decision-making, data interpretation, and ethical research practices. From there, students choose between two specialized tracks tailored to distinct career paths. The Clinical Research Administration track focuses on designing, managing, and analyzing clinical trials for drugs, biologics, and medical devices, emphasizing skills such as data analysis, medical literature interpretation, regulatory communication, and clinical trial oversight. Key courses include Clinical Trial Design and Regulatory Requirements, Clinical Trial Research Administration, Regulatory Compliance for Pharmaceuticals, Medical and Clinical Report Writing, and a capstone project that integrates practical and theoretical knowledge. In contrast, the Regulatory Science track prepares students to work in government agencies and regulated industries by focusing on compliance, policy, and legal frameworks governing healthcare products. This track emphasizes understanding regulatory systems across different regions, evaluating risk-benefit relationships, preparing regulatory submissions, and identifying gaps in policy and compliance systems, with courses such as Regulatory Affairs Capstone, U.S. Regulatory New Drug Application and Submission, and Clinical Trial Design and Regulatory Requirements. Both tracks aim to develop professionals capable of contributing to evidence generation, regulatory decision-making, and healthcare innovation. Graduates are prepared for careers in pharmaceutical companies, biotechnology firms, healthcare organizations, consulting, insurance, and government agencies, supported by strong industry demand and significant projected job growth in health sciences and regulatory fields.