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Full-time
postgraduate degree
Posted 26d ago
~40 hrs/week
Responsibilities
Create and teach a new 3-credit course on Regulatory Affairs for Cell and Gene Therapy. Responsibilities include developing the syllabus, learning objectives, and both formative and summative assessments.
Requirements
Requires a Master's degree in a field related to Cell and Gene Therapy or regulatory affairs. Candidates must have at least 4 years of professional experience working in the regulatory field.
Full job description
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
Masters Degree in field related to Cell and Engine Therapy and/or regulatory affairs, and 4+ years of working in the regulatory field.
Related keywords
MicrobiologyImmunologyCell and Gene TherapyRegulatory AffairsProduct LicensurePost-approval Life Cycle ManagementAgency InspectionsInternational Market RequirementsRisk-based ApproachCourse DesignOnline Education
About Drexel University Urban Health Collaborative
Leveraging the power of data, research, and partnerships in order to make cities healthier, equitable, and sustainable.
Industry
Public Health
Company size
11-50 employees
Headquarters
Philadelphia, Pennsylvania
LinkedIn followers
1,393
The Drexel Urban Health Collaborative was created to leverage the power of data, research, education, and partnerships in order to make cities healthier, more equitable, and environmentally sustainable. Our mission is to improve health in cities by increasing scientific knowledge and public awareness of urban health challenges and opportunities, and by identifying and promoting actions and policies that improve population health and reduce health inequities.
Offices: 3600 Market St, Philadelphia, Pennsylvania 19104, US
Leveraging the power of data, research, and partnerships in order to make cities healthier, equitable, and sustainable.
Industry
Public Health
Company size
11-50 employees
Headquarters
Philadelphia, Pennsylvania
LinkedIn followers
1,393
The Drexel Urban Health Collaborative was created to leverage the power of data, research, education, and partnerships in order to make cities healthier, more equitable, and environmentally sustainable. Our mission is to improve health in cities by increasing scientific knowledge and public awareness of urban health challenges and opportunities, and by identifying and promoting actions and policies that improve population health and reduce health inequities.
Offices: 3600 Market St, Philadelphia, Pennsylvania 19104, US