Remote Medical Writer wanted | $150 per hour
Added 2025-05-27 16:58:29 +0000 UTCCOMPANY/PUBLICATION: HYDROGEN GROUP
Deadline: 27 June 2025
JOB DUTIES:
Develop high-quality clinical and regulatory documents: protocols, IBs, CSRs, Module 2 summaries, clinical overviews, and agency briefing books.
Interpret and synthesize complex clinical data into compelling narratives.
Collaborate with cross-functional teams including project leads, biostatisticians, and regulatory affairs.
Lead document review meetings and ensure alignment across stakeholders.
Oversee outsourced writing projects and manage vendor relationships.
Ensure compliance with internal SOPs and regulatory standards.
Support timeline development, document workflows, and QC processes.
QUALIFICATIONS:
Advanced degree (MD, PhD, or PharmD) required.
6+ years of relevant medical writing experience in pharma/biotech.
Strong knowledge of GxP and the drug development lifecycle.
Proven ability to manage multiple projects and meet tight deadlines.
Excellent communication, collaboration, and organizational skills.
BONUS POINTS FOR
Experience in psychiatric and/or neurological therapeutic areas.
Familiarity with statistical analysis plans and clinical data outputs.
Leadership in cross-functional teams and document strategy.
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CONTACT INFORMATION:
Original job posting: Click here
Website: https://www.hydrogengroup.com/
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