Ophthalmology Medical Monitor/SME (Project-Based) - Remote

This role is a project-based consulting opportunity to conduct medical monitoring on an as-needed basis. This is not a full-time position.Role & ResponsibilitiesProvide medical input into the development and execution of study documents and plans, such as study protocol, IB, SMP, DMP, SAP, Lab manuals, etc.Provide medical expertise to sponsors in the drug development processProvide significant expertise as primary medical reviewer of individual adverse event reports, clinical, and safety documentsLead safety activities on assigned product(s) that may include interactions with other functional groups in the companyResponsible for medical monitoring tasks, which may include:Eligibility reviewReview of safety-related protocol‐related deviationsReview of safety dataDevelop Medical Monitor PlanParticipation in medical monitoring and/or safety review meetings as neededMedical management of queriesMedical coding reviewMaintain records and logsMedical review of study documentsResponsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulationsResponsible for strategies in monitoring and analysis of cumulative safety informationMaintains significant knowledge of global and local regulations and guidance as they pertain to medical review and safety reportingJob RequirementsMedical degree required (MD or equivalent)Specialty in Ophthalmology or comparable experience in Ophthalmology5 or more years of clinical experience and/or research experience requiredRelevant experience in safety physician, safety committee membership, medical monitoring and/or medical reviewer in pharmaceutical industryExcellent scientific writing skillsAbility to understand clinical dataProficiency with MS Office applicationsGood communication skillsStrong knowledge of current regulatory practices and domestic and international regulations#J-18808-Ljbffr