- Canon USA & Affiliates (Trenton, NJ)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and completion + Process electronic submissions (eg 3500A, 2579, Product… more
- Merck (Rahway, NJ)
- …of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting , and publication. **Specifically, the Senior Director ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- TEKsystems (Mount Laurel, NJ)
- …* Integrate batch and real-time data feeds. * Enable AI, analytics, and regulatory reporting through local data access. Engagement Model * Contract-to-Hire with ... and improve resilience. * Enable real-time data streaming, AI integration, and regulatory compliance. * Potential use of Oracle, MongoDB, and Snowflake (not… more
- Merck (Rahway, NJ)
- …including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting , and publication. **Specifically, the Senior ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Fresenius Medical Center (East Brunswick, NJ)
- …success. + Directs data entry related activities such as patient admission, regulatory reporting , billing, physician orders, lab results, vital signs, patient ... status and any other treatment related data into systems. + Ensures regulatory , compliance, and audit activities are accomplished on time. + Orients and supports all… more
- RWJBarnabas Health (Livingston, NJ)
- …Trials - Assist with enrolling patients in clinical trials, comply with regulatory reporting requirements (FACT, CIBMTR, NMDP, IRB), and facilitate research ... follow-ups, and quality meetings to support ongoing program improvements + Ensure Regulatory Compliance - Stay updated on policies and procedures from RWJUH, Rutgers… more
- Citigroup (Jersey City, NJ)
- …several global functions like Compliance, Risk including BASEL, Tax and Regulatory Reporting and firm-wide strategic initiatives. **Responsibilities:** + The ... personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency. **Qualifications:** + 10 - 14 years… more
- Sumitomo Pharma (Trenton, NJ)
- …US health care policies and programs and all relevant legal, compliance, regulatory and reporting requirements. **Education and Experience** + Bachelor's Degree; ... company compliance guidelines and ensure compliance with relevant laws and regulatory mandates. **Key Core Competencies** + Demonstrated ability to manage C-Suite… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements + Review current reporting period against historical ... medical standpoint, identify and respond to signal analysis, and submit to regulatory agency (FDA/Health Canada) within timelines to achieve 100% compliance with US… more
- Bank of America (Jersey City, NJ)
- …policies and standards, regulatory engagement, incidents management and analysis and overall reporting of data health across GRM on behalf of the DSME. This role ... enforcement of standards for robust data governance. + Prepare executive/management level reporting and other regulatory updates. + Produce recommendations for… more