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Medical Writer II

  • Job type: Contract
  • Location: New York
  • Salary: Competitive
  • Job reference: 285061/001_1552069992
  • Sector: EPM Scientific, Regulatory
  • Date posted: 08/03/2019

A fast-growing Biotech company is recruiting for a highly collaborative Senior Medical Writer to join their team based just outside of Philadelphia. They are seeking a motivated individual with science, research and/or medical writing background who would like the opportunity to be involved in the development of many new products being evaluated for the treatment of cancer.

Responsibilities:

  • Prepare Investigational New Drug (IND) applications and amendments, clinical study reports, annual reports, clinical study protocols/amendments, informed consents, investigator brochures, briefing/meeting packages
  • Handle regulatory submission requirements and processes
  • Assist with responses to questions from regulatory agencies
  • Provide writing/editing services and QC to other in-house units
  • Serve as a resource for new medical writerts
  • Lead cross functional project teams and act as a project leader with manager oversight
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