- Bayer (Newark, NJ)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... strategic partnership and collaboration with territory cross-functional stakeholders (ie Area General Manager , Area Business Unit team, Field DGOS, etc.) as part of… more
- Fujifilm (Trenton, NJ)
- …the assistance of technical support, as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Information Systems Security Professional (CISSP), Certified Information Security Manager (CISM), Certified Information Systems Auditor (CISA), Certified in ... and standards, including NIST, ITIL, GDPR, and ISO. + Understanding of FDA cybersecurity guidance, ISO 13485, IEC 81001-5-1, and NIST Cybersecurity Framework.… more
- Vitalief (New Brunswick, NJ)
- …in the EST or CST zones. Job Responsibilities: + Reporting to the Manager , Budget & Reimbursement, this financial analyst is responsible for preparing, maintaining, ... CMS regulations, and assesses compliance with other regulatory requirements, including FDA and NIH guidelines. + Negotiates budgets with sponsors, interfacing with… more
- Taiho Oncology (Princeton, NJ)
- …maintenance, and close-out. The SA I helps with the coordination of project activities, including corresponding with internal and external team members globally, ... Objectives: + Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies. + Updates internal study… more
- Sokol Materials & Services (Skillman, NJ)
- …ASQ or ISPE. + Prior experience of QC equipment Qualification and some project management experience. + Knowledge of biotech, bulk drug substance or finished product ... Proven attention to details + Comfortable working in an FDA regulated environment. About the Role DUTIES AND RESPONSIBILITIES:...Provide QA support to the Devens site and QA Manager by reviewing and approving investigations and corrective actions… more
- Cardinal Health (Trenton, NJ)
- …(General Data Protection Regulation), CCPA (California Consumer Privacy Act), FDA (Food and Drug Administration)/GxP/CSV (Computer System Validation), DSCSA(Drug ... and implement control framework across it + Hands-on experience with GRC platforms, project management tools, and service management systems, with a focus on scaling… more