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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