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Medical Writer


$45 - $55 / hour
Apply before: June 1, 2024
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  • Date posted
    May 2, 2024
  • Location
  • Salary
    $45 - $55 / hour
  • Apply before
    June 1, 2024
  • Career Level

Job Description

Regulatory Writing Senior Manager (Fully Remote Job) Location: Thousand Oaks, CA Terms: Contract W2 Duration : 08 Months Contract (Can Be Extended For Long) Hiring Manager Feedback : Need experience briefing documents with significant clinical content/Module 2/eCTD clinical summary documents And looking for 3-5 years of experience with these document types. Description: FULLY REMOTE In this vital role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include: Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans Preferred Qualifications: Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred Experience with regulatory documents in Regulatory Affairs, Research, Development or related area Experience in medical writing in the Biotech/Pharmaceutical industry