Medical Writer

US-WA-Seattle
Job ID
2017-1044
Category
Other

Overview

Dendreon is in need of a remote, seasoned Medical Writer with 7+ years of medical writing experience to provide services including, but not limited to: writing clinical sections of submissions, clinical study protocols and CSRs to support US and ROW regulatory applications.

 

This is 1 year contract with the possibility of extensions. This is a remote position. 

Responsibilities

  • Provide regulatory documents to support Pre-submission meetings, IND and/or BLA filings:
    • Use source materials from the current and/or historical Regulatory filings.
    • Assist in drafting/preparing briefing book (questions, answers, and background material) with input from team members.
    • Prepare slides to support Pre-submission Meeting(s).
  • Support filing of an IND with CFDA:
    • Includes editing of existing documents and data to satisfy CFDA requirements for an IND.
    • Prepare the proposed Clinical Study documents for IND.
  • Assist in the editing of existing documents to satisfy CFDA requirements for the BLA.
    • Prepare clinical study reports (CSRs) for new studies.
    • Prepare the clinical results section (module 2) of the BLA.
  • Prepare clinical study protocol and clinical study reports for US studies.

Qualifications

  • Minimum 7 years of medical writing experience.
  • Advanced degree in scientific discipline preferred, BS degree in science-related field plus significant experience will be considered.
  • Oncology and/or biologics experience preferred.
  • Strong skills in MS Office (Excel, Word, Power Point), including use of advanced Excel functions.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Familiarity with the eCTD structure & format; ICH E3 guidance for CSRs.

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