- Provide vision and oversight for the design, implementation and evaluation of MSRA and other clinical and regulatory curriculum.
- Work with City of Hope and other potential partner sites to align curriculum and rotations to each other and to program outcomes.
- Work with other KGI faculty, to coordinate the content and delivery of clinical/regulatory courses serving the MSRA and other programs.
- Evaluate and advise MSRA and other clinical/regulatory students.
- Support efforts to attain and maintain appropriate accreditation for programs related to clinical and regulatory affairs.
- Help recruit and evaluate qualified clinical and regulatory faculty.
- Engage in active scholarship and service.
- Perform other duties as determined by the department chair or dean.
- A minimum of 10 years of industry experience in clinical, regulatory and/or quality assurance.
- Demonstrated experience and expertise in regulatory standards for approval, manufacturing and/or use of parenteral-regulated medical products.
- A graduate degree in a life science field is preferred.
- Experience working with (or within) one or more regulatory agencies.
- Excellent oral and written communication skills.
- Experience developing and mentoring current and potential industry talent.
- Strong organizational skills and ability to manage multiple simultaneous projects and tasks.
- Prior teaching experience is desirable.
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Professor of Practice, Regulatory Affairs, Henry E. Riggs School of Applied Life Sciences - Claremont, United States - Keck Graduate Institute
Description
Job Description:
Position Overview:
Faculty, Part-time, Exempt
KGI is seeking applications for a part-time position in regulatory affairs. The successful candidate will join the Henry E. Riggs School of Applied Life Sciences at KGI (Riggs) conducting teaching, curriculum development, and leadership of the Master of Regulatory Affairs (MSRA) program. The Riggs School prioritizes teaching and research. The MSRA program is being offered jointly by KGI and the Beckman Research Institute of the City of Hope, a National Cancer Institute-designated comprehensive cancer center and a national leader in advancing research and treatment protocols. The first-year curriculum at KGI provides an interdisciplinary perspective on drug development, supplementing clinical and regulatory courses with science and business courses tailored to careers in pharmaceutical companies. The second year includes two semester-long regulatory rotations at City of Hope, clinical trial protocol development, regulatory filings and otherwise supporting the institute's clinical research activities. This position will support the existing portfolio of 15+ courses in Clinical and Regulatory Affairs, supporting both the MSRA and existing KGI degree programs.
Keck Graduate Institute (KGI) was founded in 1997 as the first higher education institution in the United States dedicated exclusively to education and research related to the applied life sciences. KGI offers innovative postgraduate degrees and certificates that integrate life and health sciences, business, pharmacy, engineering, and genetics, focusing on industry projects, hands-on industry experiences, and team collaborations. KGI employs an entrepreneurial approach and industry connections that allow students to become leaders in healthcare and the applied life sciences.
Located in beautiful Claremont, California, Keck Graduate Institute is a member of the prestigious Claremont Colleges, a consortium of five undergraduate liberal arts colleges, two graduate institutions, and The Claremont Colleges Services, which provide shared institutional support services. We seek to build an inclusive program that can engage the interests of a diverse population.
Education and Experience:
The successful candidate will have extensive experience in one or more of the following areas: clinical research, regulatory affairs, or quality assurance. Industry experience in the areas of drugs and biologics, cell and gene therapies, medical devices, and/or diagnostics is preferred.
Experience with the FDA is required, while experience with non-US regulatory bodies is highly desirable. A minimum of 10 years of industry experience in clinical, regulatory and/or quality assurance.
Essential Duties and Responsibilities : Individuals must possess knowledge, skills and abilities to perform the essential functions of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.
Required Knowledge, Skills and Abilities: Individuals must possess knowledge, skills and abilities to perform the essential functions of the position, or be able to explain or demonstrate how the essential functions may be performed, with or without, reasonable accommodations, using some other combination of skills and abilities.
Special Requirements:
Keck Graduate Institute has implemented a SARS-CoV-2 (COVID-19) and Influenza Vaccination Program covering all employees and students. Employees must submit proof of vaccination, an Institute-approved exception, or deferral to comply with the policy.
Physical and Mental Requirements
Ability to maintain good concentration level while dealing with interruptions; attention to detail with emphasis on accuracy; capable of giving, receiving, and analyzing information, formulating work plans, and articulating goals and action plans.
Sitting in a normal seated position for extended periods of time. Standing for extended periods of time. Reaching and extending hand(s) or arm(s) in any direction. Finger dexterity is required to manipulate objects with fingers rather than the whole hand(s), or arm(s), for example, using a keyboard. Communication skills using the spoken word. Ability to see within normal parameters. Ability to hear within normal parameters. Ability to bend and stoop, for example, to file. Ability to lift and carry short distances up to 20 lbs., for example to lift or move office supplies, files, books and packages. Ability to drive locally and travel by airplane nationally. Occasionally, will be required to stand for prolonged periods of time at activities/events on and off-campus. May require overnight stays.
