Post-Doctoral Pharmaceutical Industry Fellowship

Overview

The St. John's University/Forest Research Institute Fellowship takes pride in the intimate nature of the program which enables preceptors and senior Fellows to give the time and devotion necessary to provide each Fellow with the greatest experience possible.

Program Objective

The two-year fellowship is designed to develop and expand the skills of the Doctor of Pharmacy graduate to provide a foundation for a successful career in the pharmaceutical industry. Fellows will develop a thorough understanding of the drug development process with opportunities to identify and pursue areas of interest at Forest Research Institute and at St. John’s University College of Pharmacy and Allied Health Professions.

Certificate of Completion

Upon successful completion of the fellowship program, a certificate will be awarded by St. John’s University College of Pharmacy and Allied Health Professions and Forest Research Institute.

Eligibility for Fellowship

Fellows are chosen from a nationally competitive selection process. To be eligible, candidates must graduate from an Accreditation Council for Pharmacy Education accredited Doctor of Pharmacy Program and have a keen interest in pursuing a career in the pharmaceutical industry.

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Program Structure

Forest Component

Two separate two-year fellowship positions will be available, each providing the Fellow with a solid understanding of the drug development process. One fellowship will begin in Regulatory Affairs, and the other in Clinical Development. Both positions provide the Fellow with the opportunity to rotate into other areas of interest during the second year of the program.

First Year:

Regulatory Affairs

The Regulatory Affairs department serves as a liaison between the FDA and Forest Research Institute and is responsible for maintaining a positive and productive relationship. The fellow will acquire, through firsthand experience, a general knowledge of the regulatory requirements for developing and marketing a new drug. This includes the filing and maintenance of Investigational New Drug Applications (IND) and New Drug Applications (NDA) according to federal regulations and guidances. The Fellow will develop skills in providing the Project Team with strategic regulatory guidance for drug development. Additionally, the Fellow’s experience will include review of product-related promotional material for regulatory compliance.

Clinical Development

Clinical Development is responsible for the development and implementation of protocols and clinical trials from Phase II to Phase IV. The Fellow will be exposed to a variety of therapeutic indications, including depression and anxiety disorders, Alzheimer’s disease, fibromyalgia, hypertension, and pulmonary disorders.

The Fellow will join a clinical team, working with other departments, including Biostatistics, Data Management, and Field Operations, to conceptualize and implement clinical trials of various scope and size. The Fellow will assist in the development of protocols and trial materials, training of investigator sites, maintenance of ongoing trials and the analysis, interpretation and reporting of clinical trials data.

Second Year:

The Fellow will have an opportunity to pursue areas of interest in various other departments at Forest Research Institute through rotations of 3 to 6 months in duration. These departments include:

• Clinical Development
• Clinical Operations
• Drug Safety Surveillance
• Medical Affairs
• Medical Information
• Marketing
• New Products Market Research
• New Product Scientific Assessment
• Project Management
• Quality Assurance/Compliance
• Regulatory Affairs

External rotations with governmental agencies including the Food and Drug Administration are also permitted. Prior to selecting rotations, the Fellow will meet with various members from each area of FRI to discuss the operations and responsibilities of their department. These meetings also provide the Fellow with an excellent opportunity to network and orient themselves within the company.

St. John’s University Component

The Fellow will apply for an affiliate faculty appointment at St. John’s University College of Pharmacy and Allied Health Professions and will precept entry-level Doctor of Pharmacy students who are assigned to the Forest Research Institute for experiential training. Additionally, each Fellow will have opportunities at the University to participate in activities to promote professional development including: presentations, collaborative research projects with St. John’s faculty, continuing education courses, resident and fellow seminar series within the College of Pharmacy and Allied Health Professions. The Fellow may also take advantage of the numerous degree programs available at the University to further his or her own educational development.

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