Senior Medical Monitor (Remote - US)
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked 1d ago — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 11d ago
The date the source published, not the day we noticed it (2026-10-23). Last seen at its source 14h ago.
We have tracked this listing since 23 Oct 2026 (10 days). The employer's own board has carried it every time we have read it, most recently 14 hours ago.
Is it remote?
Marked remote on the employer's board
Their board carries a remote setting on this posting — a field they filled in, not wording we read. The location field names somewhere specific, which is usually where the team or the entity sits.
Who may apply?
United States
No source stated where this role may be worked. This is read from the ad's own words.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
-
JazzHR employer's own board first seen 10d ago · last seen 14h ago
- location not stated
The listing
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.
- 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.