Clinical Project Lead II Cycle Management; LCM in Vision care

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$61.00/hr - $65.21/hr

Job Title: Clinical Project Lead II for Life Cycle Management (LCM) in Vision care
Location: Remote
Duration: 06 months
Pay Range: $(61.00 - 65.21)/hr on W2 without benefits

Job Description:

• Act as the primary point of contact for the Clinical project lead and support in Life Cycle Management/Post Production Life Cycle Management activities.
• Provide clinical functional review and expertise on the assigned projects/tasks.
• Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs).
• Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead.
• Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head.
• Attend Clinical team meetings, and any other project meetings as assigned by the Project Lead and represent the function.
• Complete training activities to better understand product therapeutic area as assigned by the project lead.

Must have:

• Proficiency in European Medical device regulations (EUMDR), writing, reviewing clinical regulatory documentation.
• Experience in writing and reviewing medical and clinical evaluation documents.
• Experience in eye care/ophthalmology is preferred.
• Strong communication and writing skills.
• Master's or PhD in vision science/Optometry or foreign trained Ophthalmologist/Optometrist.

Mid-Senior level

Contract

Consulting, Health Care Provider, and Product Management

Medical Equipment Manufacturing, Medical Practices, and Pharmaceutical Manufacturing