- Sanofi Group (Morristown, NJ)
- …Safety and Pharmacovigilance (PSPV) and country PV offices in anticipation of regulatory inspections and audits. + Active involvement in the preparation, conduct, ... and follow-up of GxP regulatory inspections impacting PV until closure. + Active involvement...support for the preparation, conduct, and follow-up of Global Quality audits impacting country GxP activities, global PV processes/tools… more
- J&J Family of Companies (Raritan, NJ)
- …in a GMP state. + Support resolution of issues arising from internal quality assessments/audits, regulatory inspections, and aid in driving closure of inspection ... https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Quality Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:**… more
- RWJBarnabas Health (West Orange, NJ)
- …radiology emergency on-call program. Staff assists management in meeting regulatory requirements and department/organizational goals. Performs other duties as ... inspections appropriate to level of job competence using appropriate productivity & quality measures. Cost effectiveness is judged by completing PM & minor repairs… more
- Cytel (Trenton, NJ)
- …methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want our ... a critical role in analyzing complex manufacturing data to ensure product quality , consistency, and regulatory compliance. **As a Principal Biostatistician, your… more
- Sanofi Group (Morristown, NJ)
- …patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital partners to foster innovation and ensure best ... goals and functional expertise across other EGDS functions and EGDS TAs. ** Quality Assurance of Statistical Approaches:** + As a group head of biostatistics… more
- Fujifilm (Trenton, NJ)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Fujifilm (Trenton, NJ)
- …satisfaction and/or HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job ... Provides on-going support to resolve application related and image quality concerns on both a product and system level....with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO… more
- Sokol Materials & Services (Skillman, NJ)
- …actions (CAPAs). * Make decisions on non-conformances using a solid understanding of Quality Systems and regulatory requirements. * Review and approve documents ... GXP with at least 8 years focused on product quality . Preferred Active member of ASQ or ISPE. +...Proven attention to details + Comfortable working in an FDA regulated environment. About the Role DUTIES AND RESPONSIBILITIES:… more
- Sanofi Group (Morristown, NJ)
- …endpoint strategy implementation + Knowledge of the drug development process and the regulatory ( FDA , EMA, local agencies) and payer (EUnetHTA, NICE, HAS, G-BA, ... new COA instruments; the development of briefing books or dossiers for regulatory consideration of COAs Internal customers include primarily Research and Development… more
- Sumitomo Pharma (Trenton, NJ)
- …(ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional teams-including clinical ... writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and contributing to… more