Job Description

Medical Writer (Consultant) – Clinical Development / Early Feasibility Study

Contract-6-12+Months

Seattle, WA- Remote

Immediate Need

Candidates residing in Europe are also encouraged to apply.

Overview

We are seeking an experienced Medical Writer to support the initial drafting of a Clinical Development Plan and associated Ex-Vivo and First-in-Human (FIH) protocols for an innovative medical device program.

This is an urgent need due to approaching submission timelines. The selected writer will work closely with internal SMEs, who will provide source materials, guidance, and review support through finalization.

Following initial deliverables, there will be ongoing, intermittent protocol revision support as the program progresses through FDA review and clinical phases, with potential for long-term collaboration.

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Scope of Work

• Draft a comprehensive Clinical Development Plan
• Draft Ex-Vivo protocol (proof-of-concept in human tissue model)
• Draft Early Feasibility / First-in-Human protocol
• Incorporate SME input and manage document versioning
• Ensure alignment with regulatory expectations and submission standards

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Study Context

The program will:

• Evaluate proof of concept and efficacy of the device in healthy human cervixes removed during hysterectomy (ex-vivo study)
• Evaluate safety, efficacy, and inform device design in an early feasibility first-in-human study (pilot followed by pivotal phase)

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Preferred Qualifications

• Experience drafting clinical development plans and early-phase protocols
• Experience with medical device clinical studies
• Familiarity with Early Feasibility Studies (EFS) and/or First-in-Human trials
• IND or regulatory submission experience preferred but not required
• Strong ability to translate technical/scientific input into structured, regulatory-ready documents
• Comfortable working under tight timelines

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