Remote Medical Writer contractor

Hydrogen Group; United States; Remote; USD 312,000 - 420,000; Full time

Job summary

A leading company is seeking a Medical Writer Contractor-CNS for a home-based position. This role involves creating and managing high-quality clinical documents and collaborating with various teams in the pharma sector. The ideal candidate must have an advanced degree and significant experience in medical writing, coupled with strong organizational and communication skills.

Qualifications

• 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.

Responsibilities

• Develop high-quality clinical and regulatory documents.
• Interpret and synthesize complex clinical data.
• Collaborate with cross-functional teams.

Skills

Medical writing

Communication

Collaboration

Organizational skills

Education

Advanced degree (MD, PhD, or PharmD)

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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