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

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.