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

Confidential; Seattle (WA); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading medical device company is seeking a Medical Writer to develop clinical documents for an innovative project. This role focuses on drafting a Clinical Development Plan and protocols for early feasibility studies. Candidates should have experience with medical device studies and be able to convert complex scientific information into regulatory-ready documents. Candidates based in the U.S. and Europe are encouraged to apply. This is a remote role with an initial contract of 6-12 months.

Qualifications

• Experience drafting clinical development plans and early-phase protocols.
• Experience with medical device clinical studies.
• Familiarity with Early Feasibility Studies and/or First-in-Human trials.
• Ability to translate complex scientific input into regulatory-ready documents.

Responsibilities

• Draft a comprehensive Clinical Development Plan.
• Draft Ex-Vivo protocol for proof-of-concept.
• Incorporate SME input and manage document versioning.
• Incorporate SME input and manage document versioning; ensure regulatory alignment.

Skills

Drafting clinical development plans

Knowledge of medical device clinical studies

Familiarity with Early Feasibility Studies

Translating scientific information

Working under tight timelines

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