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SCIENTIFIC/REGULATORY WRITER

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Posting Details

Posting Details

Reference Number 40-25774
Posted Job Title SCIENTIFIC/REGULATORY WRITER
School Name Perelman School of Medicine
Org DM-Gene Therapy Program
Posted to the Web 05/03/2017
Posted Job/Salary Grade 028
Employment Type Exempt
Hours 40.00
Position Type Full Time
Position Schedule 8:00-5:00
Months 12
Position Length Contingent Upon Funding
Position End Date
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.

School/Center Overview
Duties

The Gene Therapy Program (GTP) is a complex R&D organization consisting of research laboratories supported by multiple core functions which provide internal capacity to perform gene transfer studies from basic research through phase 1 proof-of-concept human trials. The R&D enterprise has at its core a translational infrastructure that includes: technology discovery, specialized immunology assays operating under GLP, a Vector Core and Manufacturing unit that conducts GMP based assays and oversees CMOs in vector production, and a large Non-clinical program for animal testing under GLP including large nonhuman primate and mouse vivaria.

Reporting to the Executive Director (ED), the Scientific/Regulatory Writer (Writer) interfaces with scientific and regulatory personnel within the GTP and the Perelman School of Medicine to support the development of various scientific and regulatory documents necessary for the submission of IND applications. It is the Medical Writer’s role to oversee all report writing activities for the projects he/she is supporting. The Writer must ensure consistency across documents and improve overall document quality. It is the Writer’s responsibility to provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks. The Writer will prepare and/or review all final documents (i.e., study reports/protocols/ Investigator Brochures/IND submission elements, etc.).

Qualifications

In addition to requiring a Masters degree in Life Sciences, Writing or related field and 3 to 5 years of medical/scientific writing experience (or equivalent combination of education and experience), the position also requires:
- a thorough understanding of the applicable Title 21 Code of Federal Regulations and ICH guidelines
- Strong writing skills with a strong attention to detail
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- 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
- Ability to mentor and train others.
- Superior computer skills, including high-level word processing and graphic presentations.
- Experience with Microsoft Office including PowerPoint.

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.
Quick Link http://jobs.hr.upenn.edu/postings/28124

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Indeed.com
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years
  4. * Do you have a thorough understanding of the applicable Title 21 Code of Federal Regulations and ICH guidelines?
    • Yes
    • No
  5. * Do you have experience analyzing and interpreting complex data from a broad range of scientific disciplines?
    • Yes
    • No
  6. * Do you have an understanding of documentation requirements related to IND Submissions?
    • Yes
    • No
  7. * Do you have superior computer skills, including high-level word processing and graphic presentations and experience with Microsoft Office including PowerPoint?
    • Yes
    • No

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter