Remote Medical Writer/Clinical - II

Position Details

• Location: 100% remote (must be able to work EST hours)
• Rate: $81.71/hour
• Duration: 12-month contract (potential for extension or conversion)

Job Description

The successful candidate will provide medical writing for clinical regulatory documents supporting various regulatory filings. This includes Investigator's brochures, Protocols, CSRs, Agency Background Packages, and clinical modules for INDs, NDAs, BLAs, and MAAs.

Reporting to the Head of Medical Writing, you will:

• Manage assigned writing tasks, ensuring adherence to regulatory guidelines, SOPs, and style guides.
• Handle multiple documents simultaneously, ensuring high-quality, accurate, and timely delivery.
• Lead strategy and resolution meetings.
• Facilitate interactions between stakeholder organizations (Clinical, Safety, Regulatory, Non-Clinical).
• Partner with vendors to provide medical writing support.
• Contribute to process development, template creation, and SOP revisions.
• Ensure inspection readiness and support global content authoring platforms.
• Participate in CRO alliance and outsourcing activities.

Required Skills

• Bachelor of Science in Life Sciences, Nursing, Pharmacy, or related discipline (Master's/PhD/PharmD preferred).
• Minimum of 7 years of medical writing experience in the pharmaceutical industry.
• Proven experience as a lead writer for major US/EU or international regulatory submissions.
• Strong understanding of clinical development phases and processes.
• In-depth knowledge of FDA/international regulations, ICH guidelines, and CTD document preparation.

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