Job Description

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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Job Tags

Contract work, Part time, For contractors, Freelance, Remote work, Work from home

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