- Merck (Rahway, NJ)
- …figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- System One (Plainsboro, NJ)
- …consent forms, Investigator Brochures (IBs), safety updates, study reports, and regulatory submissions . + Support data management processes, including case ... report form (CRF) development and data review. + Lead development of Medical Data Review Plans (MDRPs) and perform ongoing review of clinical data for safety and efficacy. + Provide scientific input on country and site selection, feasibility assessments, and… more
- Merck (Rahway, NJ)
- …in other related function areas. Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures ... and associated documentation. + Ensure programmatic traceability from data source to analysis/modeling result. Support the development of programming standards to enable efficient and high-quality production of programming deliverables. **Educational… more
- Stryker (Mahwah, NJ)
- …activities, tolerance analysis/stack-ups, prototyping, design control updates, regulatory body submissions , manufacturing transfers and ... instruments). You will partner with our cross-functional colleagues (manufacturing, quality, regulatory , design assurance & clinical) to support a diversity of… more
- Atlas (Burlington, NJ)
- …+ Perform quality assurance/quality control of reports, proposals, client communications, and regulatory agency submissions + Supervises daily activity of a ... environmental due diligence, site characterization, remedial design and implementation, regulatory compliance, industrial monitoring, and indoor air quality** +… more
- Vitalief (New Brunswick, NJ)
- …Coordinator, with experience in patient recruiting/pre-screening/consenting/retention; activation; regulatory compliance, IRB submissions , data management ... screening, obtaining informed consent, collection of protocol required imaging, IRB submissions , study follow-up both in-patient and out-patient and data entry. +… more
- Actalent (Pennington, NJ)
- …maintain detailed project plans, timelines, and budgets. + Collaborate with regulatory teams for submissions , amendments, and compliance-related documentation. + ... trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving operational excellence… more
- Merck (Rahway, NJ)
- …understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions . + Work closely with pharmacometrics team ... external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and… more
- Stryker (Mahwah, NJ)
- …the sterilization supply chain + Main POC for all interactions with Quality regulatory bodies during submissions and supports major interruptions to supply when ... needed **Sterilization Organization and Team** + Manage, lead and develop a team of sterilization professionals , fostering a culture of excellence and continuous improvement + Allocate appropriate resources to efficiently and effectively meet organizational… more
- IQVIA (Parsippany, NJ)
- …mentoring and developing others in the use of CDISC standards + Experience in submissions to regulatory authority preferred IQVIA is a leading global provider of ... study specifications that align to the CDISC standards and regulatory agency guidance's. This position provides this guidance and...requirements as defined by FDA Guidance Documents and other regulatory guidance. + Guide clients in their use of… more
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