- Bristol Myers Squibb (Princeton, NJ)
- …a risk-based approach. **Key Responsibilities** * Monitor and assess global regulatory inspection outcomes, enforcement actions, quality and compliance metrics, and ... external signals, leveraging these insights to anticipate regulatory expectations, shape enterprise-wide inspection readiness strategies, and drive proactive,… more
- Sanofi Group (Morristown, NJ)
- …and communicate appropriately with all function stakeholders (eg clinical operations , project management, Patient Safety and Pharmacovigilance, regulatory , ... lead for one or several indications in the Development of an R&D program ** . The role requires medical leadership, organization skills and a strategically and… more
- Citizens (Iselin, NJ)
- …work experience. + Certifications Preferred: Certified Internal Auditor, Certified Regulatory Compliance Manager , Certified Fraud Examiner, Certified Public ... Your role will involve executing a robust control monitoring and testing program , managing complex risk environments, and driving continuous improvements across key… more
- Bristol Myers Squibb (Madison, NJ)
- …consultation to clinical trials teams throughout study lifecycle. + Provide regulatory intelligence on current and upcoming regulations to ensure we remain ... + Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements. + External engagement as needed with industry/trade/QA associations, … more
- Bristol Myers Squibb (Princeton, NJ)
- …study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products. This position is also responsible of ... healthcare datasets to inform evidence generation, supporting developing clinical program design, clinical trial execution, and other data-driven decision-making… more
- Bristol Myers Squibb (Princeton, NJ)
- …Records Analyst is a key contributor to the Law Strategy & Operations Function, providing comprehensive Information Governance support across global business units. ... thinking and technical capabilities, to ensure compliance with legal, regulatory , and organizational requirements. **Major Responsibilities and Accountabilities:** +… more
- Bristol Myers Squibb (Summit, NJ)
- …manufacturing and QC investigation reports in support of S12 CAR T operations . This includes execution of thorough root cause investigations, interviewing personnel, ... to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. + Experience supporting health authority inspections.… 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 (Madison, NJ)
- …Ensures studies are aligned with target label indications and are designed to meet regulatory , quality, medical, and access goals * Serves as a matrix leader to ... develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + Accountable for the… more
- Bristol Myers Squibb (Princeton, NJ)
- …across the organization, including medical safety assessment, clinical development, global regulatory , epidemiology and others. The SBRA Lead will drive functional ... the benefit-risk assessment function, aligning with organizational goals and regulatory requirements. + Lead the benefit-risk assessment process across therapeutic… more
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