Clinical And Scientific - Clinical Project Lead Ii

Job Description
Job Title:Clinical Project Lead II
Location: Irvine, CA
Duration: 12+ months
Job Description:
The contractor will be responsible/accountable for the following,
- 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
Qualifications:

• Proficient in European Medical device regulations
• 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 or foreign trained Ophthalmologist.