Regulatory Affairs Specialist (Office of Clinical Research)

Regulatory Affairs Specialist (Office of Clinical Research)

University Overview

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 Employers By State in 2021.

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.

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. For more information about Penn's vaccine requirements, visit the Penn COVID-19 Response website for the latest information.

Posted Job Title
Regulatory Affairs Specialist (Office of Clinical Research)

Job Profile Title
Regulatory Affairs Specialist

Job Description Summary
The Office of Clinical Research Regulatory team is a dynamic group of regulatory professionals. OCR Regulatory provides subject matter expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non -clinical IND enabling studies, and (iii) manufacturing for use in clinical trials, which make up the key components of a regulatory submission. In addition, the team manages Penn held INDs and IDE's, trains, and qualifies faculty sponsors, performs IND and IDE exemption determinations, and provides intensive support to faculty translating research from Penn labs into the clinical development. The Regulatory Affairs Specialist is a key contributor to the OCR Regulatory activities reporting to one of three Associate Directors who are SMEs in product development and clinical research.

Job Description

The primary responsibility of the Regulatory Affairs Specialist is to support faculty Sponsors and serve as regulatory support for Penn and faculty held INDs and IDEs. In this role, he/she will provide Sponsor leadership and training, contribute to and review core documents (consent forms, safety monitoring plans, investigator brochures, safety reporting etc.) against guidelines and regulations, and throughout the clinical trial lifecycle. Responsibilities include regulatory operations, management/compliance of the Sponsor trial master file, coordination and submission of Health Authorities submissions, ongoing vendor qualification, and maintain clinical trial registration. In addition, he/she will work closely with the OCR Regulatory Leadership to support the trial and ensure adherence to government and institutional policies and provide guidance to current and potential Sponsors in Perelman School of Medicine (PSOM).

This position will also serve a support role for OCR Regulatory leadership on sponsor activities and IND/IDE resources as well as provide guidance to Penn Faculty and Staff as assigned.

Prior experience in drug or device clinical trials and experience implementing ICH regulations is required. Attention to detail is essential.

Resume and cover letter required with application

Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required.

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. For more information about Penn's vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website for the latest information.

Targeted Pay Range: $65,000- $70,000

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.

Job Location - City, State
Philadelphia, Pennsylvania
Hybrid Eligible - This position is eligible for a hybrid work schedule with a work week divided between working onsite and working remotely.

Department / School
Perelman School of Medicine

Pay Range
$51,824.00 - $78,096.00
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.

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

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
  
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
  
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
  
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
  
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
  
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
  
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
  
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
  
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
  
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
  
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
  
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
  

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To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay


To apply, visit https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/HUP/Regulatory-Affairs-Specialist--Office-of-Clinical-Research-_JR00061234-1



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