Kyowa Kirin Pharmaceutical Development, Inc. (KKD) is an international biopharmaceutical company dedicated to improving quality of life by answering the unmet medical needs of people worldwide. KKD is a Japan-based Global Specialty Pharmaceutical Company contributing to human health and wellbeing worldwide through innovative drug discovery and global commercialization, driven by state-of-the-art antibody technologies in the core therapeutic areas of oncology, nephrology, central nervous system and immunology.
The two-year fellowship at KKD provides hands-on global experience within Regulatory Affairs allowing the fellow to develop a comprehensive understanding of the regulatory drug development process from early stage to post-marketing. The fellowship will span across therapeutic areas including oncology, immunology, and nephrology, and will encompass aspects of Regulatory Strategy, Regulatory Intelligence, and Regulatory Chemistry Manufacturing and Controls.
This is a 2-year post-graduate training program providing advanced skill training in a Global Regulatory Affairs.
This fellowship prepares individuals to pursue a career in the pharmaceutical industry.
Weekly responsibilities are split between USciences (20%) and Kyowa Kirin (80%).
The fellow will successfully complete projects related to industry, the fellowship program, and teaching responsibilities.
It is expected that as the fellow progresses through the program, the individual will be able to practice with increasing levels of independence.
Develop and cultivate core skills and competencies in analytical reasoning, critical and strategic thinking, problem solving, communication, influencing, and teamwork.
Develop professional responsibility and enhance leadership presence.
Enhance interpersonal communications with healthcare providers, strategic business partners, and consumers.
Strengthen ability to critically evaluate, interpret, synthesize, and communicate scientific information.
Instill knowledge of laws, compliance regulations, and guidance’s pertaining to medical and regulatory affairs
Advance critical thinking skills through industry-based projects and cross-functional teamwork.
Strengthen leadership and professionalism through participation in academic and industry initiatives.
Apply and communicate clinical knowledge to projects and project teams.
Global Regulatory Affairs
Develop a strong global regulatory strategy skillset while actively contributing to regulatory planning, strategy, and filings to support company assets
Develop the ability to assess development programs from a regulatory perspective
Proactively identify regulatory issues impacting program progress and development and advise management on resolutions
Obtain knowledge of country specific regulatory processes, with focus on FDA and EMA regulations and requirements
Interpret local and global regulations and apply interpretative analyses of key regulatory guidance documents as they relate to ongoing projects and submissions
Engage and Collaborate cross-functionally with a variety of departments within the company as a partner in the drug development process
Cultivate strong communication, leadership, and time management skills
Appointment to Clinical Instructor in Pharmacy Practice
Completion of a one-year teaching certificate program with responsibilities for didactic and experiential teaching and a continuing education (CE) presentation for pharmacists
Actively participate in professional development seminars and workshops designed to enhance professional growth and leadership
Contribute to the successful functioning of the fellowship program, such as facilitating student outreach, recruitment, marketing, social media, team building, etc.
BENEFITS AND COMPENSATION
USciences provides a competitive bi-weekly stipend and a comprehensive benefits package, including the option to enroll, tuition-free, in one of the University's online degree and certificate programs: MBA Pharma/Healthcare or Biomedical Writing.
PPS Interview Request
Interested candidates should submit a request for an interview through the PPS portal with a CV and a letter of intent. Candidates selected for an interview will be notified by email with the interview date & time.
Online Application Portal
Candidates must complete an online application through the USciences Application Portalby December 2, 2020. In addition, please submit the following items electronically through the portal or via mail/email to the address listed below:
Letter of intent
Three (3) letters of recommendation (sent via email to the address below)
Writing sample (drug information response is preferred)
Unofficial transcript(s) for all college coursework
Email Letters of Recommendation to:
James M. Hollands, PharmD, BCPS Fellowship Program Director PCP/USciences Mailbox 34 600 S. 43rd Street Philadelphia, PA 19104-4495 Pharmafellows@usciences.edu
KNOWLEDGE, SKILLS, AND ABILITIES:
Computer skills: Microsoft Office, email and calendar proficiency
Sufficient technology aptitude to learn new technology systems, including virtual conferencing if necessary
Medical writing proficiency
Communication skills, including formal presentations
Ability to work cross-functionally with a diverse team
Doctor of Pharmacy degree from an ACPE-accredited college of pharmacy (by the start of the fellowship program)
The fellow will be required to split their time between the university and the industry site, currently located in Princeton, NJ, approximately 50 miles from the university.
About Kyowa Kirin Pharmaceutical Development, Inc. & University of the Sciences
Philadelphia College of Pharmacy is the first pharmacy school in the nation and part of the University of the Sciences. The Department of Pharmacy Practice and Pharmacy Administration is dedicated to educating students in pharmacy, conducting research, and performing service to advance the University, the profession, and society.