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Job details

Regulatory Medical Writer

Job Summary

A company is looking for a Regulatory Medical Writer-Ad Hoc.

Key Responsibilities:
  • Author and manage regulatory documents such as Clinical Study Reports, protocols, Investigator Brochures, and Informed Consent Forms
  • Ensure compliance with FDA, EMA, and ICH guidelines for all regulatory documents
  • Collaborate with cross-functional teams to gather and verify source information and support medical device documentation


Required Qualifications:
  • Bachelor's degree in life sciences or a related field with at least 5 years of medical writing experience
  • Proven experience in writing regulatory documents including CSRs, protocols, and ICFs
  • Familiarity with EU Medical Device Regulation and experience with MDR-compliant documentation
  • Strong understanding of regulatory requirements and guidelines (FDA, EMA, ICH)

Average salary estimate

$0 / YEARLY (est.)
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$0K
$0K

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FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
No info
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
July 8, 2025

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