Remote Clinical Regulatory Documents Medical Writer

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Thu, Feb 11, 2021

This job expires in: 13 days

Job Category: Writing

Remote Level: 100% Remote

Employer Type: Staffing Agency

Career Level: Experienced

Education Level: Masters

Job Summary

A recruiting and talent acquisition firm needs applicants for an opening for a Remote Clinical Regulatory Documents Medical Writer.

Core Responsibilities Include:

  • Prepare clinical study reports (CSRs), subject narratives and clinical investigator brochures
  • Prepare protocols briefing documents, clinical sections of Investigational New Drug (IND) Applications & New Drug Applications (NDAs)

Skills and Requirements Include:

  • Advanced degree in life or health sciences
  • AND 3+ years of medical writing experience in a pharmaceutical company
  • Broad knowledge of the drug development cycle and regulatory standards
  • Knowledge of current best practices and regulations regarding the documents noted above
  • Keen attention to detail
  • Outstanding organizational and project management skills

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