- Merck (Rahway, NJ)
- …Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines ... Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- Nestle (Bohemia, NY)
- …Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety , pharmacovigilance , manufacturing, engineering ... of new GxP systems to support NHSc product portfolio. Serve as Project Manager for technology implementations, including coordination and management of external… more
- Bristol Myers Squibb (Princeton, NJ)
- …including, Non-Clinical Quality, Product Development Quality, Clinical Quality, Pharmacovigilance Quality, Quality Risk Management, and Innovative Capabilities. We ... manufacture, testing and distribution of clinical supplies (investigational products) including drug substance and drug product batch disposition, support… more
- BeOne Medicines (San Mateo, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports; + Clinical sections of Health Authority Briefing… more
- AbbVie (North Chicago, IL)
- …markets, business operations, and emerging issues. Ensures that staff provides project -related education of investigators, study site personnel, and AbbVie study ... and the review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. As needed, provides senior expert medical… more
- BeOne Medicines (Emeryville, CA)
- …in clinical development, program leadership, biometrics, clinical operations, safety / pharmacovigilance , regulatory, molecular diagnostics, and translational ... applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports + Clinical sections of Health Authority Briefing… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …inspection readiness across all clinical trial sites, clinical and Pharmacovigilance (PV) operations. + **Audit Management:** Oversee the planning, execution, ... Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data… more
- AbbVie (North Chicago, IL)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversees project -related education of investigators, study site personnel, and AbbVie study ... integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
- AbbVie (North Chicago, IL)
- …AbbVie's customers, markets, business operations, and emerging issues. Oversees project -related education of investigators, study site personnel, and AbbVie study ... integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is… more
- ThermoFisher Scientific (San Diego, CA)
- …presents sponsor meetings, provides medicines and device development consultation to clients and project team members in direct support of sales efforts. + Serves as ... effectively with key internal directorates including Operations, Biometrics, Regulatory, Pharmacovigilance , and Global Product Development to ensure the best… more