Medical reputed company (Consultant) – Clinical Development / Early Feasibility Study

Medical reputed company (Consultant) – Clinical Development / Early Feasibility Study Contract-6-12+Months Seattle, WA- Onsite Immediate Need reputed company We are seeking an reputed company Medical reputed company to support the initial drafting of a Clinical Development Plan and associated Ex-Vivo and First-in-reputed company (FIH) protocols for an innovative medical device program. This is an urgent need due to approaching submission timelines. The selected reputed company will work closely with internal SMEs, who will reputed company reputed company 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 (reputed company-of-concept in reputed company tissue model) Draft Early Feasibility / First-in-reputed company 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 reputed company of concept and efficacy of the device in healthy reputed company cervixes removed during hysterectomy (ex-vivo study) Evaluate safety, efficacy, and inform device design in an early feasibility first-in-reputed company study (reputed company 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-reputed company trials IND or regulatory submission experience preferred but not required Strong ability to translate technical/scientific input into reputed company, regulatory-reputed company documents Comfortable working under tight timelines Apply tot his job Apply To this Job