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.
Reference Number: 40-25774
Salary Grade: 028
Employment Type: Exempt
Org: DM-Gene Therapy Program
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.
Job Family: A-General/Professional Administrative