About the role
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 studies. * Review participant eligibility, protocol deviations, adverse events, laboratory data, vital signs, and other safety-related clinical data. * Support protocol development, Investigator's Brochures, Medical Monitoring Plans, Safety Management Plans, and other clinical study documents. * Respond to investigator and site safety inquiries and provide medical guidance throughout study conduct. * Participate in Data Monitoring Committees, Safety Review Committees, and cross-functional study team meetings. * Works cross-functionally with team members in other service lines. * Provide significant expertise as primary medical reviewer of individual adverse event reports. * Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials. * Aggregate case analysis, safety summaries and safety signal generation. * Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company. * Responsible for strategies in monitoring and analysis of cumulative safety information. * Provide medical and technical reviews of safety sections of regulatory documents and NDA/BLA submissions. * Guide 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 documents. * Lead and/or participate in safety surveillance and signal management activities * Guide safety updates of company core data sheet and local product labels. * Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees. * Serve as a medical subject matter expert for sponsors and project teams. * Ability 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 updates. * Experience with aggregate data review for ongoing clinical trials. * Experience 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 medications. * 5+ years of medical monitoring experience, clinical experience and/ or research experience required. * Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA). * Excellent scientific writing skills. * Ability to understand clinical data. * Proficiency with MS Office applications. * Strong communication skills. * Strong knowledge of current regulatory practices and domestic and international regulations.