Fellowship Brochure 1726585426
Fellowship Brochure 1726585426
Fellowship Brochure 1726585426
PHARMACEUTICAL INDUSTRY
FELLOWSHIP PROGRAM
In partnership with
A MESSAGE FROM OUR
CHIEF MEDICAL OFFICER
“Dear Prospective Fellow,
CONTENTS
A Message from our Chief Medical Officer .................... 2
American Regent has a long history in the pharmaceutical community. Since the launch of our company under the name
American Quinine in 1967 to our recent product launches of Tralement (2020), Multrys (2021), and an expanded indication
for Injectafer for patients with heart failure (2023), American Regent keeps the health of patients as our guiding principle.
American Regent is a leading manufacturer of high quality generic and branded specialty injectables. We maintain a robust
and diversified pipeline for future growth encompassing multiple disease indications, along with a proven record of fast-
tracking both NDAs and ANDAs with innovative regulatory strategies. American Regent remains in an excellent position
for future growth because of our capabilities in the area of pharmaceutical product development. Our development
capabilities include hormones, controlled substances, cytotoxic molecules, imaging products, antibiotics, nutritional
products, and complex generics (peptides, microspheres, lipid based nano-carriers drug delivery systems).
The American Regent team is committed to providing the ever-changing healthcare marketplace with a growing and
diversified portfolio of branded and generic specialty injectable products for healthcare providers and their patients.
Tralement®
(trace elements injection 4*, USP)
*Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg.
Paclitaxel
Protein-Bound Particles
for Injectable Suspension
(Albumin-Bound)
Injectafer®, the Injectafer® logo, Venofer®, and the Venofer® logo are trademarks of Vifor (International), Inc., Switzerland.
Tralement® is a registered trademark of American Regent, Inc.
Multrys® is a registered trademark of American Regent, Inc.
Patents pending.
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American Regent Timeline
A team of experts
founded American
Quinine to supply Tralement® (trace
high-quality elements
parenteral Venofer® (iron injection*, USP),
products to sucrose injection, the first
medical USP), now the #1 Injectafer® (ferric FDA-approved Selenious Acid
communities in selling IV iron in carboxymaltose trace elements Injection, USP is
the US and the US,* is injection)* is FDA injection is launched in a
Canada approved Approved introduced single-dose vial
1967 2000 2013 2020 2022
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MEDICAL AFFAIRS
Pharmacists in the Medical Affairs Department provide efficient and unbiased medical information concerning the
company’s pharmaceutical products to healthcare professionals, consumers, and internal associates.
Currently recruiting one fellow for 2025-2027
• Manage company expectations while effectively integrating key clinical messages for dissemination to a wide array
of audiences
• Acquire the medical expertise and experience to thrive in the pharmaceutical industry while complying with FDA
and PhRMA regulations
• Shadow the Medical Science Liaison (MSL) team and attend relevant
conferences to deepen their understanding of Medical Affairs in a
professional, pharmaceutical industry setting
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FELLOWSHIP ELECTIVE ROTATIONS
The second-year fellow will have the option to rotate through a variety of functional areas to foster professional
growth and to identify areas of interest.
Second Year Rotations:
Second Year
Electives
*Second-year elective rotations include, but are not limited to Clinical Research and Development, Regulatory Affairs, Safety/
Pharmacovigilance and Commercial & Marketing. Rotation availability is subject to change.
• Work with Clinical Operations to manage and update study time lines and budgets, and participate in the processes
of ongoing data review, analysis, and reporting while understanding the roles and responsibilities of clinical team
members
• Understand the lifecycle of clinical trials, identify study milestones, and develop study timelines that align with the
clinical development plan
• Utilize clinical research skills inclusive of systematic literature reviews, oral and written communication skills, and the
preparation of abstracts, articles in scientific journals, and study training materials for internal and external stakeholders
Regulatory Affairs:
• Gain an understanding of the regulations, guidelines, standard practices, and roles of Regulatory Strategy in the
development of products for commercialization
• Provide strategic input to support the development, filing, and regulatory approval of new drug products
• Participate in planning and preparing for interactions with Regulatory Health Authorities, and generate responses to
inquiries
• Contribute to drafting regulatory documents and participate in filing and maintaining Investigational New Drugs (INDs)
and New Drug Applications (NDAs)
Safety/Pharmacovigilance:
• Develop an understanding of pharmacovigilance processes within the Argus Safety Database
• Prepare and review aggregate reports under the supervision of the PV Department
• Participate in surveillance and signal detection for company products in a variety of different therapeutic areas
• Translate pertinent clinical study results into marketing and educational tools
• Develop the required skills to synthesize information, generate insights, formulate solutions, and present findings to
internal and external stakeholders
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PROGRAM LEADERSHIP
“The American Regent Medical Affairs Fellowship represents an excellent opportunity for
a PharmD to gain pharmaceutical industry experience and expand their clinical knowledge
through active participation on the Medical Affairs team.
“The American Regent Medical Affairs Fellowship is geared for highly motivated
individuals seeking to enhance their careers and obtain pharmaceutical industry
experience. This two-year program provides a unique opportunity for fellows to develop
key skills in Medical Affairs while offering flexibility to explore additional functional areas
based on personal interest. The fellows become an integral part of the American Regent
team and will gain experience in understanding strategy implementation to support
scientific and commercial goals. This fellowship program will provide direct mentorship
to foster professional growth and development as well as essential experiences for a
successful career in the pharmaceutical industry.”
“It is an honor and pleasure serving as Faculty Coordinator for this wonderful post-
doctoral fellowship opportunity offered through St. John’s University and American
Regent. Fellows completing this exceptional two-year program are highly marketable and
stand to secure cutting-edge positions within the pharmaceutical industry primarily due to
the mentorship, professional project opportunities, research experience, and exposure to
multiple cross-functional areas within American Regent.”
“For the past 15 years St. John’s University, College of Pharmacy and Health Sciences,
has partnered with American Regent to provide Doctor of Pharmacy graduates with
structured postgraduate education fellowships that develop leadership, practice, research,
and teaching skills to succeed in the industry today and in the future. The University is
proud of its longstanding affiliation with American Regent and the success of our past
and current fellows.”
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CURRENT FELLOWS
“The American Regent and St. John’s University fellowship program offers
the prospective fellow a unique opportunity to explore various elements
of Medical Affairs, as well as other areas of interest in different functional
areas that align with their professional goals. This robust fellowship program
within a mid-sized company is structured to be flexible to allow the fellow to
gain invaluable experience and create a meaningful impact in the business.
All of the mentors are always ready to lend a helping hand to help you reach
your goals for the most rewarding experience.
The academic component at St. John’s University allows the fellow to gain
research and teaching experience, as well as participate in graduate degree
programs. At St. John’s University, you will truly feel like you are part of
a family with amazing mentors that promote personal and professional
growth, networking, and expanding your knowledge and skills. This
program will set a foundation for a successful career in the pharmaceutical
industry.”
“The American Regent and St. John’s University fellowship program enables
fellows to develop the essential skills needed to become competitive
professionals in the pharmaceutical industry. This fellowship is unique
because it allows fellows the freedom to choose areas of interest and make
specific goals. All mentors in the program are dedicated to providing the
best possible learning experiences. The program’s structure allows fellows to
gain an understanding of the various areas within Medical Affairs.
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FELLOWSHIP PRECEPTORS
9
ALUMNI HIGHLIGHT
Medical Affairs
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St. John’s University College of Pharmacy and Health Fellows at St. John’s:
Sciences provides undergraduate, graduate, and post-
doctoral programs focused on global impact, which The fellow will be a full time St. John’s University
cultivates the tools necessary to find solutions to employee. A competitive stipend will be provided, as
complicated healthcare issues. Located in Queens, NY, St. well as options for comprehensive health, dental, and
John’s commitment to excellence and renowned faculty vision insurance.
inspire students to practice patient-centered care and
shape the future of healthcare. Each fellow is responsible for completing a semester-long
teaching requirement at the university and an additional
St. John’s University will empower diverse learners fellowship research project that may include original
with quality education for life. Through innovative research, or the development, enhancement, or evaluation
teaching, research, and service we will foster rational, of some aspect of operations or patient care services.
spirited inquiry and intelligent reflection. Our student
centered approach will be shaped by a caring, energized, Upon Fellowship Completion:
nimble culture. Enlivened by our distinctive mission, our
graduates will excel in the competencies and values
required for leadership and service in a rapidly evolving Certificate of Completion
global community. As a Catholic and Vincentian university, Teaching Certificate
we will be known worldwide for addressing issues of
poverty and social justice.
Additional Fellowship Opportunities:
Potential applicants for the St. John’s University/American Regent fellowship programs must meet the following criteria:
• Graduate from an Accreditation Council for Pharmacy Education (ACPE) accredited Doctor of Pharmacy Program
How to Apply:
stjfellowships@stjohns.edu
Schedule an Interview:
Virtual interviews will be provided upon submission of a Letter of Intent and CV beginning early November.
Note: The American Regent fellowship recruits yearly for Medical Affairs. Fellowships are remote with professional
development days located on the St. John’s University campus in Queens, NY.
Questions:
Please contact stjfellowships@stjohns.edu for any and all questions regarding the fellowship program or
application process.
Recognizing that the choice of a Post-Doctoral Industry Fellowship is an important decision, AIFA exists to promote a
common aspect of each of our program’s cultures by supporting a consensus first offer date of December 16, 2024
for all Fellowship candidates.
We hope that other academic and non-academic Fellowship Programs will respect this timeline to allow for best
program fit for candidates.
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American Regent
5 Ramsey Rd
Shirley, NY 11967
www.americanregent.com
In partnership with
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