The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job TitleRegulatory Affairs Specialist C (Office of Clinical Research)Job Profile TitleRegulatory Affairs Specialist SeniorJob Description SummaryThe Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols. The Regulatory Affairs Specialist C contributes to core documents (protocols, Informed Consents, investigator brochure, Monitoring Plans, etc) and reports, and is responsible for preparing submissions to FDA and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application).Job Description
The Regulatory Affairs Specialist C functions independently with minimal supervision on complex protocols. The Regulatory Affairs Specialist C contributes to core documents (protocols, Informed Consents, investigator brochure, Monitoring Plans, etc) and reports, and is responsible for preparing submissions to FDA and facilitates all communications with the reviewing entities (including FDA and other federal/state/local agencies, per application).
The Regulatory Affairs Specialist C will need to be aware of legal agreements needed and/or planned and ensure appropriate information is included and addressed. The Regulatory Affairs Specialist C, sends submissions to the FDA, via electronic means, where available and feasible.
Support faculty sponsors and OCR regulatory leadership on topics related to GCP, TMF, Health Authority Submissions, Sponsor responsibilities and trainings.
Duties:
Qualifications
Bachelor’s degree and 5-7 years’ research experience required; at least 2 year’s regulatory experience preferred. Associated research credentialing (RAC, CCRP, CIP, etc.) are highly recommended or preferred to be completed within 1 year of employment.
COMPETENCIES:
Resume and cover letter required with application
COVID-19 vaccination is a requirement for all positions at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University.
Targeted Pay Range: $77,920- $86,000
This Targeted Pay Range is only applicable to this job posting. All salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Job Location – City, StatePhiladelphia, Pennsylvania
Hybrid Eligible – This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.
Department / SchoolPerelman School of MedicinePay Range$61,046.00 – $86,000.00 Annual RateSalary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile. Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.Special Requirements
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.University Benefits
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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