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Emily – Medical/Technical Writer

ServiceCreative
IndustryPharmaceuticals
Job CategoryContent Development & Management
Skill

Emily is a Medical Writer and Technical Writer with five years of experience in writing protocols, amendments, ICFs, CSRs (Phases I-IV), and IBs. She has worked with Johnson & Johnson, Sepracor, Glaxosmithkline and Veristat.  She is the lead writer for the Japanese division of her company which focuses on global medical writing and translation. In one of her recent projects, she wrote clinical study reports for Japanese, Korean and Ireland based biomedical clients. Her work involved correcting English translations and clarifying complex medical protocols. Additionally, she has over 11 years’ experience as a Technical Writer working with Applied Research and DTRA/ITT Industries. She is finishing her Master’s of Science Degree in Biomedical Writing from the University of the Sciences in Philadelphia. She currently has a BS degree from Brigham Young University.

Sampling of Projects:

  • At Juno Therapeutics, Emily was responsible for writing biotech business plan prior to corporate start-up including medical rationale, product descriptions, manufacturing facility descriptions, intellectual property summaries, key personnel backgrounds and management organization.
  • At Fred Hutchinson Cancer Research Center, Emily wrote and edited eCTD compliant FDA submissions for both CDER and CBER. Submissions included pre-IND applications, IND/IDE applications, annual reports, amendments (clinical and CMD), Appendix M responses, and invention disclosure forms.
  • At SGS Life Science Services, Emily wrote and edited journal articles with scientist on a global basis where English was not the native language. The articles were focused on pharmaceutical / biotechnology audiences and pertained to manufacturing process controls, quality controls and drug development
  • At Johnson & Johnson, Emily wrote peer reviewed manuscripts for the American Journal of Sports Medicine evaluating the performance of surgical treatment for articular cartilage lesions located on the femoral condyle of the knee in comparison to the standard micro fracture procedure.

Education/Certification

  • BS, Psychology, Brigham Young University
  • BA, Media Arts / Writing, Brigham Young University
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