Clinical Project Lead II for LCM in Vision Care
Join a leading team in Life Cycle Management (LCM) for Vision Care! Seeking a clinical expert with experience in EUMDR, medical / clinical writing, and ophthalmology / eye care to support regulatory documentation and post-production risk reviews.
Location: Fort Worth, TX (Onsite preferred, candidates will be considered for remote work within CST or EST time zones).
Essential Duties and Responsibilities:
- 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
Required:
- Master's / PhD Vision Science / Optometry OR Foreign Ophthalmologist / Optometrist
- EUMDR proficiency
- Clinical regulatory documentation (writing / reviewing)
- Medical / Clinical evaluation documents (writing / reviewing)
- Strong communication skills
- Strong writing skills
Preferred:
- Eye care / Ophthalmology experience