Senior Medical Monitor (Remote - US)

About MMS 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 an 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-leading employee retention. 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 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 www.mmsholdings.com or follow MMS on LinkedIn. Roles And Responsibilities Provide medical oversight for Phase I-IV clinical trials and observational studiesReview participant eligibility, protocol deviations, adverse events, laboratory data, vital signs, and other safety-related clinical dataSupport protocol development, Investigator's Brochures, Medical Monitoring Plans, Safety Management Plans, and other clinical study documentsRespond to investigator and site safety inquiries and provide medical guidance throughout study conductParticipate in Data Monitoring Committees, Safety Review Committees, and cross-functional study team meetingsWorks cross-functionally with team members in other service linesProvide significant expertise as primary medical reviewer of individual adverse event reportsGuide adverse event coding, retrieval and analysis activities in drug safety and clinical trialsAggregate case analysis, safety summaries and safety signal generationLead safety activities on assigned product(s) that may include interactions with other functional groups in the companyResponsible for strategies in monitoring and analysis of cumulative safety informationProvide medical and technical reviews of safety sections of regulatory documents and NDA/BLA submissionsGuide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs)Guide and coordinate preparation of ad-hoc benefit-risk assessment documentsLead and/or participate in safety surveillance and signal management activitiesGuide safety updates of company core data sheet and local product labelsGuide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committeesServe as a medical subject matter expert for sponsors and project teamsAbility to work independently as well as able to integrate with client clinical and safety teams Job Requirements Medical degree (MD, DO, or international equivalent),Experience with protocol amendments and ICF updatesExperience with aggregate data review for ongoing clinical trialsExperience as a clinical scientist who is responsible for timely assessment of the clinical trial data and participation in safety surveillance activities for assigned studies in Phase I-III, including review of medical history, labs, vital signs, medications, and prohibited medications5+ years of medical monitoring experience, clinical experience and/ or research experience requiredExcellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA)Excellent scientific writing skillsAbility to understand clinical dataProficiency with MS Office applicationsStrong communication skillsStrong knowledge of current regulatory practices and domestic and international regulations