- Merck & Co. (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.Core Responsibilities may include ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global...executed in Global Regulatory Affairs and Clinical Safety .Ensure organizational compliance with global regulations… more
- Aequor (Bothell, WA)
- …Electrophoresis, Microscopy, Cleaning AKTA equipment, Lab Notebook Maintenance, Lab Safety Protocols, Regulatory Compliance )3. Organizational/Training Skills ... (Lean Six Sigma)Soft Skills:1. Interpersonal and Adaptability Skills: Builds positive relationships and communicates effectively within a team. Adjusting to different roles and responsibilities as needed to support team objectives.2. Effective Communication:… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance , safety and production goals are ... are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company… more
- Merck & Co. (Lower Gwynedd, PA)
- …to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready ... activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements relative to their role.Experience working within… more
- Merck & Co. (Durham, NC)
- …meet established delivery timelinesProvide active support during audits and inspections ( regulatory , internal, safety )Collaborate with site compliance team ... cGMP-compliant state and represent the laboratory during audits and inspections ( regulatory , internal, safety )Build and maintain strong relationships with site… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... and independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global ... and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic reporting. Serves as the key DSI contact for PV service… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT)… more
- Merck & Co. (North Wales, PA)
- …strategies that meet regulatory requirements and ensure patient safety , quality and compliance .-Oversee PV processes: Responsible for overseeing ... Manager - PV Case Intake and Processing. Reporting into Product Line Lead Patient Safety and Quality & Compliance , this position will be responsible for managing… more
- Merck & Co. (Durham, NC)
- …Quality Control will be responsible for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Merck & Co. (Durham, NC)
- …Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation ... for the company; uses this knowledge in own workUnderstands and applies regulatory / compliance requirements relative to their roleInfluence, motivate, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical ... ISO, EU and ICH. Understand 21 CFR Part 11, cGAMP, and other regulatory guidance associated with computer / automation based systemsAbility to read electrical… more
- Merck & Co. (Rahway, NJ)
- …Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA ... GMP Operations team.Ensure inspection readiness and offer prompt support during regulatory , quality, and safety inspections.Address audit findings and identify… more
- Merck & Co. (Rahway, NJ)
- …and accurate information and status updates to project sponsors and management.Champion compliance and safety ; promote a culture of diversity, inclusion, and ... manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for ... rare diseases and immune disorders. Summary This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team (GPT) as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …existing CMR employee on-boarding, cultural engagement, technical/role-specific training and GxP/ Regulatory compliance across CMR functions. Position will serve ... execution, maintenance of technical training across all CMR functions, and compliance across clinical development, medical, and regulatory roles/processes/SOPs… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plant processesDevelop and maintain electrical and control schematics while ensuring compliance with safety and regulatory standardsProvide technical ... support for system commissioning, start-ups, and ongoing maintenance both locally at multiple facilitiesPeriodically review technology advancements to provide a competitive advantage through continued education, seminars, and trade shows to provide a… more
- Merck & Co. (Rahway, NJ)
- …risk management, performance monitoring, continuous improvement activities that ensure the safety , effectiveness, and compliance of the company's products.- The ... supply chain efficiencies, and improve product stewardship practices, while ensuring compliance with regulatory requirements.6. Foster a culture of excellence,… more
- Merck & Co. (Rahway, NJ)
- …such that the process is scalable without compromising stability, safety , efficacy, and delivery. -During development, we leverage smart experimental ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
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