- J&J Family of Companies (Titusville, NJ)
- …regulatory agency interactions. + Independently create study protocols, analysis plans, and statistical programming deliverables including analytical dataset, ... a roadmap to deliver the projects from data feasibility, study design and analysis , to final presentation to senior cross-functional leaders. + Partner with the Data… more
- JPMorgan Chase (Jersey City, NJ)
- …and implement AI/ML solutions to automate, optimize and enhance model risk analysis and control testing + Evaluate adherence to model development standards, ... and procedures through conducting robust data driven quantitative and qualitative analysis and directly partnering with model developers, model users, model… more
- Merck (Rahway, NJ)
- …global auditing team + Maintain up-to-date knowledge base with respect to emerging regulatory trends and changes in regulations and standards to incorporate into the ... to these requirements. + Provide updates to company stakeholders on GxP and regulatory trends as well as the auditing program's ability to detect compliance to… more
- Merck (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... field. Expertise in independently conducting and directing the planning, execution, analysis , and documentation of all stages of cell culture process… more
- Sanofi Group (Morristown, NJ)
- …of sanofi revenues by expediting submission timelines and facilitating reviews by regulatory agencies of sanofi key assets. + He/she: Creates and executes a ... + Utilizes creative, thoughtful and boundary-pushing strategies, and performs risk analysis , to propose and lead organizational and process transformations to… more
- Merck (Rahway, NJ)
- …understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications. + Extensive experience with ... transfer using immunoassay techniques. + Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual HCPs… more
- Merck (Rahway, NJ)
- …stages of clinical development, as well as process characterization and regulatory filings for successful commercialization. + Improve upstream processes by ... and problem-solving skills. + Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through conference… more
- J&J Family of Companies (Raritan, NJ)
- …plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today ... of the long-term supply strategy including scenario development and E2E impact analysis . + Proactively monitor technical process and product performance to detect… more
- Bristol Myers Squibb (Princeton, NJ)
- …on translational data generated to support asset development and contribute to regulatory submissions. This individual will work on cross-functional project teams to ... scientists, as well as BMS members from clinical, medical, commercial, regulatory , and diagnostics. Individual will also engage with external academic… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …fate/effects studies and environmental risk assessments according to appropriate international regulatory guidelines. This role will lead and participate on diverse ... risk assessments and environmental fate/effects studies focused on global regulatory frameworks, technical knowledge and emerging scientific trends; Lead matrix… more