The role involves processing drug safety cases independently and leading the development of high-quality safety narratives and deliverables. The associate will act as a Subject Matter Expert, managing client meetings and ensuring compliance with regulatory guidelines.
MMS
18 Remote Job Openings at MMS
Senior Pharmacovigilance System Architect (Argus Administrator) - SA Based, US EST Hours
MMS
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Full Time
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6 days ago
MMS
Serve as the Database Administrator for Argus Safety, managing configuration, maintenance, and E2B reporting via gateway technologies. Provide technical leadership for system upgrades, case migrations, and regulatory alignment with Eudravigilance standards.
Lead the design and optimization of scalable clinical data engineering solutions to support regulatory compliance and advanced analytics. Partner with cross-functional teams to transform raw clinical data into standardized, CDISC-compliant formats and high-performance data architectures.
Lead the full life-cycle of KerusCloud support and statistical services, including study design, simulation, and the preparation of protocols and analysis plans. Provide statistical consultancy to sponsors and collaborate with product development to define key features of trial simulation software.
The Senior Medical Writer is responsible for authoring and editing complex clinical development documents, including protocols and regulatory summaries. They must manage project timelines, coordinate directly with clients, and mentor junior medical writers.
The role involves generating tables, listings, and graphs from clinical trial databases using SAS. The programmer will also develop specifications and deliverables adhering to SDTM, ADaM, and regulatory submission standards.
Generate tables, listings, and graphs from clinical trial databases using SAS and the System Development Life Cycle. Lead study or small programming project teams to ensure regulatory submission challenges are met.
Provide medical expertise on cardiac safety concerns and perform medical monitoring tasks throughout the development process. Lead safety activities and review adverse event reports and clinical safety documents for assigned products.
The Senior Medical Writer is responsible for authoring and editing complex clinical development documents, including protocols and study reports, while ensuring scientific rigor. They will manage project timelines, coordinate directly with clients, and mentor junior medical writers.
The Medical Writer is responsible for authoring and editing critical clinical development documents, including protocols, investigator's brochures, and clinical study reports. They will manage project timelines, coordinate directly with clients, and mentor other medical writers within the team.
The CSR Narrative Writer is responsible for writing safety documents and patient CSR narratives for regulatory submissions. They will manage document revisions and ensure compliance with ICH and regulatory guidelines.
The CSR Narrative Writer is responsible for writing safety documents and patient CSR narratives for regulatory submissions. They will manage document revisions and ensure compliance with ICH and regulatory guidelines.
Business Intelligence Analyst- Clinical Operations (India, Hybrid/Remote)
MMS
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Full Time
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2 months ago
MMS
Develop business requirements and specifications to create Power BI dashboards and reporting pipelines for clinical operations. Mentor team members in data science methodologies and manage the end-to-end development of data models.
The Senior Biostatistician is responsible for developing Statistical Analysis Plans (SAPs), creating randomization schedules, and producing high-quality statistical analyses for phase 1-4 studies. They lead projects, manage client meetings, and provide statistical support for Data Safety Monitoring Boards and regulatory submissions.
Lead the generation of tables, listings, and graphs from clinical trial databases using SAS and SDLC methodologies. Manage project tasks independently while providing guidance to junior colleagues and supporting business development activities.
The Medical Writer will critically evaluate and interpret medical literature to draft and edit complex clinical development documents such as protocols and study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Medical Writer will critically evaluate and interpret medical literature to produce high-quality clinical development documents such as protocols and study reports. They will also manage project timelines, coordinate directly with clients, and mentor team members throughout the writing process.
The Medical Writer will evaluate and interpret medical literature to support study design and write various clinical development documents. They will also mentor other writers and manage project timelines effectively.
