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About Drexel University

Located in the heart of Philadelphia, Drexel University is a world‐class, comprehensive, R1 research institution and a global leader in experiential education. For more than 100 years, our renowned Cooperative Education (co-op) program has enabled students to gain professional work experience before they graduate, setting them apart from their peers.

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Drexel offers its highly engaged faculty and professional staff a comprehensive and world‐class benefits package that includes generous vacation and paid time off as applicable (including civic engagement days), up to an 11% 403(b) Retirement Plan match with immediate vesting, and remote and flexible work options for many roles. Our exceptional medical plans include domestic partner and fertility assistance and our award‐winning A Healthier U wellness program. In addition, faculty and professional staff at Drexel enjoy free tuition for themselves and their dependents for Drexel degree programs, certification, and non‐certification programs. And as part of the tuition offering to employees, Drexel participates in a tuition exchange program for dependents with other higher education institutions. These are just a sample of our extensive benefit offerings. Please see this Benefits Brochure for more information.

Adjunct - DUCOM - Regulatory Affairs for Cell and Gene Therapy 2

Apply now Job no: 504364
Work type: Full-Time
Location: Remote
Categories: Drexel University, College of Medicine

About the Department of Microbiology and Immunology

The Drexel University College of Medicine’s Department of Microbiology and Immunology and the Institute for Molecular Medicine and Infectious Disease is searching for an Adjunct to create and teach the new course MIIM 574S Regulatory Affairs for Cell and Gene Therapy 2. This 3-credit course explores cell and gene regulatory affairs from product licensure and into post-approval life cycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, and international market requirements for cell and gene regulatory affairs. Specific focus will be on developing skills in formulating regulatory strategies from a scientific, risk-based approach by exploring hypothetical scenarios hypothetical scenarios a regulatory affairs professional may encounter.

Job Summary

This position is fully online and will require periodic meetings with Drexel faculty and support staff to facilitate the creation and roll-out of these new courses.

Essential Functions

1. Course syllabus according to Drexel’s specifications.

2. Course welcome message (desktop video preferred).

3. Course introduction text synchronous or an asynchronous format.

4. Weekly overview and conclusion/summary.

5. Each week’s topics will include learning objectives and assessments.

6. Formative assessments (e.g., self-assessments, practice exercises) and summative assessments (e.g., graded quiz, assignments, papers. The adjunct should be available for at least two conference calls or virtual meetings with online course development team at Drexel to discuss course specifics.

Required Qualifications

  • Master's degree in field related to Cell and Engine Therapy and/or regulatory affairs, and 4+ years of working in the regulatory field.

Advertised: Eastern Standard Time
Applications close: Eastern Daylight Time

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Drexel University is an Equal Opportunity/Affirmative Action employer that welcomes individuals from diverse and neurodiverse backgrounds and perspectives, and believes that an inclusive and respectful environment enriches the University community and the educational and employment experience of its members. The University prohibits discrimination against individuals on the basis of race, color, national origin, religion, sex, sexual orientation, disability, age, status as a veteran or special disabled veteran, gender identity or expression, genetic information, pregnancy, childbirth or related medical conditions and any other prohibited characteristic. Please visit our Policies page to view all University policies related to Human Resources and News and Announcements for workplace postings.

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