- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally with internal ... actions items, risks, and decisions to the team. With direction from management , manages multiple regulatory submission projects, including the development of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …the Global Senior Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to analysis of requirements and resource ... with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives. + A digital-native, change -embracing mindset, with a… more
- Olympus Corporation of the Americas (Westborough, MA)
- …. **Job Description** This role is responsible for coordinating and managing regulatory activities across the Digital Unit (DU). The Digital Unit is a ... This individual will play a key role in establishing and assessing regulatory strategies and requirements for digital health products and solutions, ensuring… more
- Delek US Holdings (Dallas, TX)
- …Compliance, & Risk Management + FLSA Status: Exempt + Job Function: Regulatory Affairs and Compliance + Job Level: Professional III **JOB SUMMARY** Maintains the ... + Relationship Management + Acts as a knowledgeable resource for Regulatory Compliance, specifically DOT 195, TRRC (comprehensive, safety, OQ, CRM, D&A, state of… more
- SMBC (New York, NY)
- …Outside Business Activities and Personal Account Dealing) + Financial Crimes Compliance + Regulatory Change Management + Compliance Alerts and other ... new regulations and regulatory developments through the Regulatory Change Management process. +...regulatory concerns and other significant matters to their manager . + Communicate policies, procedures and new regulatory… more
- Olympus Corporation of the Americas (Westborough, MA)
- …information. + Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management . + As needed assist in the development ... Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports regulatory… more
- Acuity Brands (Costa Mesa, CA)
- …other enterprise platforms. The PDM Manager will oversee all product change management , BOMs, regulatoryand trade compliance, ensuring robust data accuracy, ... us at www.acuityinc.com . **Job Summary** The Product Data Management (PDM) Manager will lead QSC's enterprise-wide...Lifecycle Management ** - Manage the full Product Change Management processes: ECR, ECO, MCO, LCO,… more
- Genmab (NJ)
- …a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications Creates quality control ... regulations/guidance's Creates any needed documentation and training for standard processes, change control management and tools Responsible for defining… more
- Merck & Co. (Rahway, NJ)
- …, quality and other supply chain areas to address clinical supply and/or change management related topics. Responsible and accountable for establishing the ... #eligibleforERP GCScareers GCScareer25 #PSCS #VETJOBS Required Skills: Adaptability, Adaptability, Change Control Processes, Change Management , Clinical… more
- SMBC (New York, NY)
- …supports institutional clients with comprehensive payment and liquidity solutions. The Product Manager will be responsible for the end-to-end management of ... to deliver scalable, client-centric solutions that meet evolving market and regulatory demands. + Oversee product lifecycle management , including ideation,… more
- Merck & Co. (Rahway, NJ)
- …(SOP) execution. - #eligibleforERP GCSCareer25 #PSCSRequired Skills: Adaptability, Change Management , Clinical Research, Cross-Functional Team Leadership, ... Drug Development, Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management , Regulatory Compliance, Risk Management , Sourcing… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Manager , Contracts and Vendor Management , is responsible for overseeing the Information ... is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently...System's contract lifecycle and software asset management strategy. This role ensures compliance with best practices,… more
- Merck & Co. (Durham, NC)
- …shift positions, 12.5 hour rotation (2-2-3). - - The role of Operations Manager at our Company's Durham drug substance manufacturing facility is a manufacturing ... employee development, routine 1:1 meetings and coaching, recognition, and performance management ). Additionally, they must become proficient in the use of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the team to be effective.Strong track record in executing effective project management in cross-functional teams within IT, clinical, regulatory , pharmaceutical ... in the treatment of multiple myeloma.Legend Biotech is seeking MES Project Manager as part of the Manufacturing Excellence team based in Raritan, NJ.Role… more
- Repligen (Waltham, MA)
- … Management (user provisioning, privileged access, segregation of duties) Change Management (system updates and configuration changes)IT Operations ... the design and operating effectiveness of ITGCs across Logical Access, Change Management , System Operations, and IT Governance.Conduct IT application… more
- Premera Blue Cross (Mountlake Terrace, WA)
- …from home opportunity! Please note this position aligns to PST business hours.** The ** Manager , Case Management ** Team is a Supervisor for Case Managers. This ... our employees. Working at Premera means you have the opportunity to drive real change by transforming healthcare. To better serve our customers, we are fostering a… more
- Xcel Energy (Denver, CO)
- …wide array of stakeholders. Manages all processes related to scope, cost control, change management and risk mitigation in alignment with organizational best ... **Position Summary** Provides strategic leadership while directing program and project management activities for selected, highly complex projects, which may impact… more
- Merck & Co. (Rahway, NJ)
- …(RaDS) value team in our Company's R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... scientists' ability to discover and develop innovative medicines that change the course of human health. In the RaDS...enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management and oversight of phase I-IV ... of all clinical trial activities in compliance with GCP and relevant regulatory guidelines.Detailed management and oversight of regional trial activities, as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Facility Support Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Facility Support Manager is at an exempt level working within the...space walkthroughs to ensure GMP compliance.Actively participate in all regulatory and internal audits of the facility.Participate in the… more
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