- Bristol Myers Squibb (New Brunswick, NJ)
- …manufacturing equipment. This role is critical to ensuring compliance with regulatory standards and maintaining the highest levels of cleanliness and safety ... expertise for evaluation and feedback of methods. + Ensure compliance with regulatory requirements (eg, FDA, EMA) and industry standards (eg, cGMP, ICH) related… more
- Merck (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products. The incumbent must be able to ... ensure full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions. + Lead the… 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 ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Colgate-Palmolive (Piscataway, NJ)
- …with internal entities such as the Product Development, Legal and Regulatory departments as well as external groups including subsidiaries, trade associations ... Product Development, Consumer Affairs, Legal Department, Government Affairs, and Regulatory Affairs. + Representation of Colgate's key business interests on… more
- Pfizer (Peapack, NJ)
- …contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports ... understanding of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-Clinical, Pharmacology, Quality Assurance. + Experience… more
- Merck (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …from the manufacturing process, design parameters, and control strategies enables regulatory filings to bring these novel medicines to patients worldwide. **Role ... support the transition of such processes from our labs to clinical supply, to regulatory filings and manufacturing vendors. As a member of our process team, you will… more
- Merck (Rahway, NJ)
- …Generate tables, listings, and graphics required for clinical trial decision-making, regulatory requests, clinical study reports, and new drug application filing. ... Produce SAS data transport files and program text files for regulatory submission. Assure high quality and timely deliverables. Communicate and collaborate… more
- Merck (Rahway, NJ)
- …data. + Produce tables and graphics for inclusion in study reports and regulatory submissions. + Produce SAS transport files and associated documentation for ... regulatory submissions. + Assure deliverable quality and compliance with departmental SOPs and good programming practices. + Collaborate effectively with project team… more
- Deloitte (Jersey City, NJ)
- …IT teams to integrate AI workflows. + Collaborate with legal teams to meet regulatory standards for tax data. + Perform model audits to identify and mitigate risks. ... + Monitor and optimize generative models for performance and scalability. The Team Deloitte Tax LLP's Tax Transformation Office (TTO) is responsible for the design, development, and deployment of innovative, enterprise technology, tools, and standard processes… more