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Senior Scientific & Regulatory Writer (Gene Therapy Program-Quality Assurance & Regulatory Affairs)

Employer
University of Pennsylvania
Location
Philadelphia

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Administrative Jobs
Technology, Analysts & Programming
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details



Senior Scientific & Regulatory Writer (Gene Therapy Program-Quality Assurance & Regulatory Affairs)

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.

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
Senior Scientific & Regulatory Writer (Gene Therapy Program-Quality Assurance & Regulatory Affairs)

Job Profile Title
Manager Research Project C

Job Description Summary
The Gene Therapy Program (GTP) is entering a new era of unprecedented opportunity with the great potential to reshape the face of medicine as we know it. Our discoveries have set the stage for successful treatments and possibly even cures for devastating genetic diseases.
The laboratory of Dr. Jim Wilson, at GTP of the University of Pennsylvania, has been a leader in the development of innovative vector technology for close to three decades. We have emerged as the “go-to” organization for public and private partners, who want to participate in the gene therapy space. Currently, we are positioned to lead another round of vector innovation and establish pre-clinical and clinical proof-of-concept in therapeutic applications of in-vivo genome editing.

Continuation of all GTP positions is contingent upon funding.

Job Description

Due to continued growth of our program, we are searching for a Senior Scientific/Regulatory Writer. The position reports to the Executive Director of Regulatory Affairs and it responsible to interface with scientific and regulatory personnel within the GTP to support the development of scientific and regulatory documents (IND/CTA/BLA/response documents) necessary for the submissions to Global Health Authorities. Overall project management of submissions from document(s) content, identification of contributors and establishment of their responsibilities, development and ensure timelines are maiintained for document(s) preparation and finalization. Lead the authoring of the documents and ensuring final document quality, including ensuring consistency across documents. Development of Best Practices for content development, preparation and publishing/printing of Regulatory documents. Maintenance/development of protocol, report, CTD template, and other regulatory documents are also within the scope of responsibilities. Assist with implementation of electronic document storage, tracking of document preparation and timelines. Train GTP personnel contributing to documents as well as newly hired scientific/regulatory writing personnel.

Qualified candidates will have a minimum of 5 years experience as a technical/scientific and regulatory document writer, understanding of applicable regulations and guidance requirements for document content, preparation, and final electronic formatting for Global Health Authorities such as the US FDA, UK MHRA, Health Canada, EU/EMA, LATAM, JAPAC areas. Ability to work independently and lead the contributing teams by providing guidance on content and document preparation to the Health Authorities.

Qualifications:
  • Masters degree in Life Sciences, Writing or related field and 5 to 7 years of medical/scientific writing experience (or equivalent combination of education and experience); PhD preferred.
  • Thorough understanding of the applicable Title 21 Code of Federal Regulations and ICH guidelines.
  • Superior writing skills with strong attention to detail a must!
  • eCTD experience strongly preferred.
  • Ability to analyze and interpret complex data from a broad range of scientific disciplines.
  • Ability to work independently and lead the contributing teams by providing guidance on content and document preparation to the Health Authorities.
  • Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
  • Understanding of documentation requirements related to IND submissions.
  • Superior computer skills, including high-level word processing and graphic presentations.
  • Experience with Microsoft Office including PowerPoint.


Job Location - City, State
Philadelphia, Pennsylvania

Department / School
Perelman School of Medicine

Pay Range
$72,837.00 - $138,391.00

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 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/Translational-Research-Laboratories/Senior-Scientific---Regulatory-Writer--Gene-Therapy-Program-Quality-Assurance---Regulatory-Affairs-_JR00037067





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Organization

Welcome to the University of Pennsylvania! Penn is the largest private employer in Philadelphia and is a world-renowned leader in education, research, and innovation.  

Across our 12 highly-regarded schools, more than 25,000 students, and more than 4,000 faculty members, we become one university: a wide-ranging, ever-changing community that draws its strength from a multitude of races, ethnicities, genders, sexual orientations, historical traditions, ages, religions, disabilities, veteran status, interests, perspectives, and socioeconomic backgrounds. 

Penn carries on the principles and spirit of its founder, Benjamin Franklin: entrepreneurship, innovation, invention, outreach, and a pragmatic love of knowledge. Franklin's practical outlook has remained a driving force in the university's development. To learn more, visit About Penn

Vision

 

As engines of knowledge and new ideas, universities have the unique potential to define the future rather than be defined by it; to pioneer change rather than merely manage it. To do so requires a plan both visionary and pragmatic. The Penn Compact 2022 motivates community members to innovate, be radically inclusive, and positively impact their local, national, and global communities. 

 

Penn’s fundamental priorities — increasing access, integrating knowledge and engaging locally, nationally and globally — are supported by the three core values that make us uniquely Penn: inclusion, innovation, and impact. 

 

Learn about the signature initiatives of the Penn Compact 2022:  

 

Diversity 

 

Understanding and appreciating diversity is one of Penn's most important priorities and is fundamental to success in today's world. 

 

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. 

 

To learn more about Diversity and Inclusion at Penn visit: 

 

Benefits 

 

Penn offers a wide range of benefits and perks - from Penn's retirement Matching Plan to bike repair stations to access to the full LinkedIn Learning library to adoption assistance to workshops at the letterpress and book arts studio and much more! 

 

Campus and Beyond

 

We invite you to explore our campus and its stately buildings and state-of-the-art facilities. 

 

Try our self-guided tour! Come and visit

 

Learn about sustainability at Penn

 

News 

 

Stay up-to-date with Penn's response to COVID-19: Coronavirus Information & Resources

 

Penn supports news publications that tell the ongoing story of the University community, communications services for external media, telephone and video services, and other media resources: Campus Media 

 

Connect with us!  

 

Instagram: @uofpenn 

Twitter: @Penn 

 

 

Company info
Telephone
(215) 898-7372
Location
3451 Walnut Street
Philadelphia
PA
19104
US

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