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Associate Director E, Regulatory Affairs (Office of Clinical Research)

Employer
University of Pennsylvania
Location
Philadelphia County, PA
Closing date
Jun 24, 2022

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Sector
Pharmaceutical, Regulatory Affairs
Organization Type
Corporate
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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 Penns 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 Americas 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 Penns vaccine requirements and the use of Penn Open Pass, visit the Penn COVID-19 Response website (https://coronavirus.upenn.edu/) for the latest information.

Posted Job Title

Associate Director E, Regulatory Affairs (Office of Clinical Research)

Job Profile Title

Associate Director E

Job Description Summary

The Associate Director of Regulatory Affairs will be a part of the Office of Clinical Research Regulatory team which is a dynamic group of regulatory professionals. Collectively, 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. This position will provide the non-clinical and IND enabling study expertise. In addition, the Regulatory team manages Penn held INDs and IDEs, 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 Associate Director is a part of the leadership team and one of four Associate Directors who are SMEs in product development and clinical research.

Job Description

The Office of Clinical Research (OCR) Regulatory Unit, together with the Perelman School of Medicine (PSOM) is seeking an Associate Director of Regulatory Affairs to support medical innovation from bench to bedside with experience in preclinical research. This position is responsible for leading the development, review, and execution of regulatory strategy and operations for drugs and devices throughout the product lifecycle with a focus on early development. The Associate Director (AD) will join a dynamic leadership team that collaboratively supports all aspects of early-stage and expanded use product development including nonclinical, quality, and clinical expertise. The AD will work closely with basic science faculty to educate, support and train on nonclinical activities with the goal of facilitating development, mitigating institutional risk, and managing vendors. This role will also support the unit Director in serving as a consultant and liaison with institutional oversight, support, and development organizations for translational research activities. The AD will manage a team of regulatory associates responsible for the day-to-day oversight and health authority reporting of clinical trials and nonclinical studies including the preparation and critical review of high-quality IND, IDE, and CTA submissions. This position will work in tandem with the Director of the Sponsor Support Unit to evaluate new projects for resource needs and allocation as well as assessment of the units strategic growth and development through collection and analysis of unit metrics and activities. In addition to product development support, the leadership team is responsible for guidance and support of faculty members engaging in various aspects of product development including Regulatory Sponsorship, Manufacturing, and clinical or nonclinical activities. This includes training and consultation in alignment with institutional, local, state, and federal regulations and policies.

Cover letter and resume required with application.

COVID-19 vaccination is a requirement for all employees at the University of Pennsylvania. New hires are expected to be fully vaccinated before beginning work at the University

Educational Qualifications:

Master's degree required. MD or PhD preferred.

Required Experience:

Minimum 5-7 years of job-related experience or equivalent combination of education and experience required.

Responsibilities:
  • Consult with faculty and staff on product development and regulatory related topics with a nonclinical focus
  • Ensure research projects are conducted in compliance with federal, state, local and university policies
  • Ensure unit activities are high quality, appropriately resourced, and in alignment with the leadership teams strategic standards and goals
  • Conduct quality review of all submissions, reports, core documents, and other key sponsor materials for all projects
  • Ensure proper guidance, exemption determinations and sponsor qualification and training is provided
  • Risk mitigation and escalation when needed
  • Establish and maintain best practices and PSOM policy and procedures (SOPs)
  • Use and establish best practices for electronic submissions and document management systems
  • Track and report on assigned unit metrics
  • Maintain current regulatory knowledge and evaluate implications on unit activity and processes/procedures
  • Function as a regulatory representative in discussions with Health Authorities.
  • Monitor national and international requirements through Health Authority news announcements, reviews of publications, seminars, and direct communication with outside regulatory personnel.
  • Prepare and submit reports to senior management, as required.

Salary:

The job pay range encompasses the full range of employees from new hires to the salaries of Penn employees with many years of experience and seniority and is not a precise indicator of salaries of new hires when looking at the top end. Based on what we pay employees coming into this position our pay range is $100,000- $110,000, based on education and experience above the minimum qualifications

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$74,476.00 - $117,086.00

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 familys 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. Penns 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 familywhatever 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 youre newly hired, you wont 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. Thats 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 Universitys libraries and athletic facilities, or visit our arboretum and art galleries. Theres always something going on at Penn, whether its 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, youre right in the middle of the excitementand 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.

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