What are the responsibilities and job description for the Clinical Project Lead II for Life Cycle Management (LCM) in Vision care position at Aequor Information Technologies Pvt. Ltd.?
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
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 Opthalmologist/Optometrist.
Note: There are around 50 Universities in the US that offer Vision Care Science degrees
Salary : $60 - $64