- Merck & Co. (Rahway, NJ)
- … Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor ... experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory ... Process Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant… more
- Eisai, Inc (Nutley, NJ)
- …the development and execution of an omnichannel strategy for global MA/MSL training that is personalized, integrated with Eisai systems , and data-driven.Support ... we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution of Global Medical… more
- Aequor (Athens, GA)
- …and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air. ... Conduct regular inspections and preventative maintenance to ensure systems are operating efficiently and safely. Engage in technical activities/troubleshooting… more
- Twist BioScience (South San Francisco, CA)
- …of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our ... continuous improvement, technical excellence, robust software development practices, and regulatory compliance.Software Development & Implementation: Oversee the full Software… more
- Aequor (Thousand Oaks, CA)
- … training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Preferred Qualifications ? Ability to adhere ... handling is a plus, but not required, as full training will be provided. Strong attention to detail, good...to regulatory requirements, written procedures and safety guidelines? Ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... cohesive, high performing teams with a strong sense of mission, providing training and mentoring to build sufficient management depth throughout the organization and… more
- AUROBINDO (Durham, NC)
- …and office management Special projects, as needed including introducing and training employees on HR systems and processes.ResponsibilitiesRecruitment & ... with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a… more
- Aequor (Athens, GA)
- …management systems and migration of records from legacy systems . Electronic Document Management (controlled documents, regulatory submission documents): ... Provide routine user support. Electronic Document Management (controlled documents, regulatory submission documents): Be the first line of user support… more
- Merck & Co. (Durham, NC)
- …electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems ).Required Experience and Skills:Familiarity of regulatory requirements ... such as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI.- Develops Standard Operating Procedures (SOPs) and… more
- Merck & Co. (Durham, NC)
- …electrical, plumbing, advanced mechanical, HVAC, and/or multi-stage refrigeration systems ).Required Experience and Skills:Familiarity of regulatory requirements ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Process Equipment (eg Filling Machine,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …theory, thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly ... Knowledge, and Skills:cGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, OSHA ... provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes a collaborative work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Sr. Director, Wegovy Consumer Marketing . C ollaborates with sales, marketing, training , and finance teams to ensure alignment with business objectives and ... regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and...consumer interactions, and making recommendations for execution improvements Health Systems Strategy Support Collaborate with medical affairs and market… more
- Eisai, Inc (Nutley, NJ)
- …pathway).Engage and influence key customers (including local and regional hospital systems ) to sustain a strong organizational presence in the Alzheimer's ... key stakeholders that influence decision-making within local markets and healthcare systems ).Experience working with healthcare delivery systems (including buy &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to the Director of HCP/KOL Marketing. Collaborates with sales, marketing, training , and finance teams to ensure alignment with business objectives and ... regulatory requirements. Essential Functions Brand/Therapy Area Management o Support...data to inform strategy adjustments and improve execution Health Systems Strategy Support o Collaborate with medical affairs and… more
- Merck & Co. (Durham, NC)
- …of calibration activities with the Planning and Scheduling team.Support training program for calibration technicians.Works as a liaison between Maintenance, ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Support… more
- Merck & Co. (Rahway, NJ)
- …ability to learn new concepts outside of core expertise and training --Excellent verbal and written communication skills, demonstrated creativity, and strong ... beneficial.-Demonstrated commitment to diversity and inclusion-Experience with IT, computerized systems , software and applicationsExperience leading a team for a… more
- Eisai, Inc (Nutley, NJ)
- …best practices that can help simplify the patient journeyIdentify and ensure training (product, disease state and compliance training ) for promotional speakers ... the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according… more
