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

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit  or follow MMS on .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 regulationsPowered by JazzHR

Created: 2026-04-15