Medical Writer (Consultant) – Clinical Development / Early Feasibility Study
Medical Writer (Consultant) – Clinical Development / Early Feasibility Study
Contract-6-12+Months
Seattle, WA- Onsite
Immediate Need
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.
________________________________________
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
Support revisions during FDA review process
Ensure alignment with regulatory expectations and submission standards
________________________________________
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)
________________________________________
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
Apply Now
Apply Now
Contract-6-12+Months
Seattle, WA- Onsite
Immediate Need
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.
________________________________________
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
Support revisions during FDA review process
Ensure alignment with regulatory expectations and submission standards
________________________________________
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)
________________________________________
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
Apply Now
Apply Now