Remote Medical Writer contractor

This range is provided by Hydrogen Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range

$150.00/hr - $150.00/hr
Medical Writer Contractor-CNS (Home-based)

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.
...

Seniority level

Seniority level Mid-Senior level
Employment type

Employment type Contract
Job function

Job function Writing/Editing
Industries Hospitals and Health Care, Non-profit Organizations, and Government Administration
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