Loading...

@

  • Regulatory Affairs Specialist (Abramson Cancer Center)(Remote... Philadelphia
  • University of Pennsylvania in Philadelphia, PA, United States
  • jobs
  • 2 days ago

jobs description

Regulatory Affairs Specialist (Abramson Cancer Center)(Remote
Eligible
...
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 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 Title

Regulatory Affairs Specialist (Abramson Cancer Center)(Remote
Eligible)

Job Profile Title

Regulatory Affairs Specialist

Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania
is a world leader in developing and conducting innovative clinical
trials for the prevention, diagnosis, and treatment of cancer. The
ACC Clinical Research Unit (CRU) is instrumental in the development
and implementation of cancer clinical trials that offer
cutting-edge oncology treatments. The ACC CRU is currently
comprised of 14 Research Teams that support disease/discipline
specific cancer programs within the ACC. Contingent upon
funding.

Job Description

The Abramson Cancer Center (ACC) of the University of Pennsylvania
is a world leader in developing and conducting innovative clinical
trials for the prevention, diagnosis, and treatment of cancer. The
ACC Clinical Research Unit (CRU) is instrumental in the development
and implementation of cancer clinical trials that offer
cutting-edge oncology treatments. The ACC CRU is currently
comprised of Research Teams that support disease/discipline
specific cancer programs within the ACC. Contingent upon
funding.

The CRU Regulatory Affairs Office seeks a full-time Regulatory
Affairs Specialist to participate in the coordination of Phase
I-V clinical trials. Reporting to the Regulatory Affairs Research
Teams Manager, the Regulatory Affairs Specialist will, with
minimal supervision, prepare and process all regulatory
documentation through the IRB, CTSRMC, FDA and all applicable
regulatory review committees- including new submissions, continuing
reviews, amendments, adverse events, and reportable events. He/she
will, with minimal supervision, prepare and process all
required regulatory documentation for pharmaceutical companies,
contract research organizations (CROs), the NCI and the FDA, as
well as, organize and maintain all regulatory affairs
documentation/files as required. The Regulatory Affairs
Specialist is expected to resolve regulatory and data queries
as required, and participate in initiation, monitoring, audit and
close-out visits. He/she will participate in study team meetings,
research team meetings, and ongoing protocol training/compliance
meetings. The Regulatory Affairs Specialist is expected to
facilitate the development and submission of FDA IND
applications and annual reports, and development/maintenance of
study specific case report forms and source document tools, as well
as, to provide direct regulatory/compliance guidance and
facilitate investigator initiated trials and
investigator-initiated multi-site trials. Additional duties
relevant to regulatory affairs as assigned.

DUTIES:

Reporting to the Regulatory Affairs Manager, the Regulatory
Affairs Specialist will, with minimal supervision,
prepare and process all regulatory documentation through the IRB,
CTSRMC, FDA and all applicable regulatory review committees-
including new submissions, continuing reviews, amendments, adverse
events, and reportable events. He/she will, with minimal
supervision, prepare and process all required regulatory
documentation for pharmaceutical companies, contract research
organizations (CROs), the NCI and the FDA, as well as, organize and
maintain all regulatory affairs documentation/files as required.
The Regulatory Affairs Specialist is expected to resolve
regulatory and data queries as required, and participate in
initiation, monitoring, audit and close-out visits. He/she will
participate in study team meetings, research team meetings, and
ongoing protocol training/compliance meetings. The Regulatory
Affairs Specialist is expected to facilitate the
development of investigator-initiated research protocols, the
development and submission of FDA IND applications and annual
reports, and development/maintenance of study specific case report
forms and source document tools, as well as, to provide direct
regulatory/compliance guidance and facilitate investigator
initiated trials and investigator-initiated multi-site trials.
Additional duties relevant to regulatory affairs as assigned.

Qualifications:

Bachelor's degree preferably in a life science or human subject
protection field and 3-5 years research experience or an equivalent
combination of education and experience required. At least 1 year
regulatory experience preferred. Experience conducting high risk
biomedical research and/or oncology regulatory research experience
preferred. Associated research credentialing (CCRP, CIP, etc.)
preferred.

Working Conditions:

This position is intended to be largely remote. Candidate must
agree to use a remote workspace that is conducive to working, free
of hazards and other dangers to people and equipment. Abramson
Cancer Center, Clinical Research Unit strongly recommends the
candidate set up a separate area. Equipment should be placed where
it is adequately supported. The candidate remains obligated to
comply with all University rules, policies, practices and
instructions that would apply if the candidate were working on the
premises of the University. The candidate agrees to ensure
arrangements are made for dependent care and confirms non-work
related interests will not compete with work requirements during
the designated regular work hours. The candidate will be
responsible for determining any tax implications of maintaining the
remote workspace. The candidate will be responsible for complying
with any and all local township codes, rules, regulations, and
zoning ordinances which could affect the ability to use the
designated remote workspace.

Position contingent upon continued funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$51,824.00 - $63,600.00 Annual Rate

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.



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/Perelman-Center-for-Adv-Medicine/Regulatory-Affairs-Specialist--Abramson-Cancer-Center--Remote-Eligible-_JR00084220-1

jeid-b638ec8ca1a9ec40a1ff45a9be86521f
Philadelphia PA USA

salary-criteria

Apply - Regulatory Affairs Specialist (Abramson Cancer Center)(Remote... Philadelphia