Senior Medical Monitor (Remote - Canada)

MMS Holdings Inc; Vancouver; Remote; CAD 120,000 - 180,000; Full time

Job summary

MMS Holdings Inc is seeking a Medical Reviewer to provide expert medical oversight across Phase I–IV trials, with emphasis on safety data, regulatory alignment, and cross-functional collaboration. You will review complex clinical data, guide safety analyses, and contribute to regulatory documents and submissions.

The role requires strong scientific writing and experience with ICH, FDA, and EMA guidelines, along with excellent communication skills to liaise with sponsors and project teams.

Qualifications

• MD/DO or international equivalent required.
• 5+ years of medical monitoring experience.
• Experience with protocol amendments and ICF updates.
• Experience reviewing safety data from Phase I–III trials.
• Strong knowledge of ICH, FDA and EMA regulations.
• Excellent scientific writing and communication skills.

Responsibilities

• Provide medical oversight for Phase I–IV trials and observational studies.
• Review participant eligibility, adverse events, lab data, vital signs for safety.
• Support development of Safety Plans and other regulatory documents.
• Respond to safety inquiries and provide medical guidance during studies.
• Participate in Data Monitoring Committees and cross-functional study teams.
• Collaborate with other service lines to integrate safety insights.
• Lead primary medical review of individual adverse event reports.
• Guide safety data coding, retrieval, and analysis activities.
• Lead and coordinate safety surveillance and signal management activities.
• Guide regulatory reporting such as ICSR, PSURs, and NDA/BLA submissions.

Skills

Medical oversight

Clinical data review

Safety surveillance

Regulatory knowledge

MS Office proficiency

Education

Medical degree (MD/DO or international equivalent)

Tools

Regulatory databases

Job description

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 inthecompany.
• 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 reportsummary 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+ yearsof 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.