Telecommuting Clinical and Regulatory Document Contract Medical Writer

Job is Expired
Location: New Jersey
Compensation: Salary
Staff Reviewed: Mon, Jan 22, 2018

Job Summary

A staffing company has an open position for a Telecommuting Clinical and Regulatory Document Contract Medical Writer.

Core Responsibilities Include:

  • Ensuring that all clinical study and submission documents for projects are prepared, reviewed, and approved in a timely manner
  • Write Clinical Study Reports and CSRs
  • Create safety updates and regulatory submissions (eCTD modules 2.5 and 2.7)

Applicants must meet the following qualifications:

  • Contractor will be requested to attend required meetings in Northern, NJ
  • Must have at least 5-7 years of experience with "hands-on" experience writing the below clinical/regulatory documents
  • Experience with clinical trial registry and disclosure activities
  • Thorough understanding of GCP and ICH guidelines
  • Able to prioritize and self-manage
  • Knowledge of summary level documents

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