Gene Therapy Program | University of Pennsylvania

Regulatory Writer

The Gene Therapy Program (GTP) and Orphan Disease Center (ODC) are 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.

We are on the hunt for a Regulatory Writer to support the development of various scientific and regulatory documents necessary for the submission of IND applications.

In this role, you will oversee all report writing activities for the projects you are supporting; ensure consistency across documents and improve overall document quality; provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks; prepare and/or review all final documents (i.e., study reports/protocols/ Investigator Brochures/IND submission elements, etc.).

As a top candidate for this role, you will possess:

  • 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)
  • Thorough understanding of the applicable Title 21 Code of Federal Regulations and ICH guidelines
  • Superior writing skills with a strong attention to detail a must!
  • eCTD experience strongly preferred. 
  • 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.

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.

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