- Insmed Incorporated (NJ)
- …while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding that ... to Executive Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries,… more
- Santander Holdings USA Inc (Boston, MA)
- …or equivalent field. - Preferred. * 5+ Years of experience in AML/KYC, Risk Management , Internal Controls, Regulatory Compliance , including direct engagement ... Associate, Business Control & Risk Management (AML/KYC) Scroll down to...risk issues impacting the Business Line. Understand where operational , strategic, reputational, compliance , and model risks… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical… more
- Merck & Co. (Rahway, NJ)
- …/ compliance requirements relative to design controls and risk management activities. Position Qualifications: Education Minimum Requirement: BA/BS ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial master file is complete and accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart- ... (eg protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)Ensure operational study-level timeline, budget, deliverables and quality management .Facilitate… more
- Insmed Incorporated (NJ)
- …across all Insmed locations and functions. The position will be responsible for minimizing risk to employees, visitors within operational lab assets or in office ... management systems, including documentation, standard operating procedures (SOPs), risk assessments, incident investigation protocols, reporting and emergency response… more
- Eisai, Inc (NJ)
- …and mitigate risks.Process Management Supports functional strategy execution and risk management initiativesDepartmental Subject Matter Expert (SME) and may ... key liaison across internal teams and external partners, the Director drives operational excellence, risk mitigation, and inspection readiness while fostering… more
- Merck & Co. (Rahway, NJ)
- …Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk Management {+ 4 more}Preferred Skills: Current ... IT administration.#eligibleforERP#PSCS#GCScareerRequired Skills: Accountability, Accountability, Applied Engineering, Automation, Change Management , Combination Products, Communication, Compliance Packaging, Cross-Functional… more
- Fresenius Medical Care (Olmito, TX)
- …Emergency Preparedness Plan; ensure maintenance of equipment . Ensure proper medical records management and HIPAA compliance . Oversees the continuous and data ... responsible for the leadership of the clinical facility ensuring all clinical, operational , and business objectives are met. The Facility Administrator is authorized… more
- ValSource, Inc. (Rahway, NJ)
- …projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with ... identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting projects with our clients… more
- Merck & Co. (North Wales, PA)
- …managing the supply of direct and indirect materials, performing the supplier relationship management , supply risk assessment with actions in place and regular ... role includes leading the team to support overall category management for the packaging category led by the global...scope of services under the supplier are executed in compliance with the contract and in a timely manner.… more
- Insmed Incorporated (NJ)
- …validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated systems through ... You'll also:Provide oversight and manage multiple projects at the same time.Provide operational support like change controls, release management , and reviews of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for completeness, accuracy; identify necessary SME reviewers such as Quality, Safety, Compliance , IT based on business understanding and risk assessment; ... choices, drive core operations and develop insights to drive growth and operational excellence across the value chain while innovating for future capabilities. Our… more
- Eisai, Inc (Nutley, NJ)
- …issues and mitigate risks.Process Management Drives functional strategy and risk management initiatives.Develops competency models and designs training and ... Clinical Outsourcing provides strategic leadership for global outsourcing and vendor management activities within clinical development. This role is accountable for… more
- Merck & Co. (Rahway, NJ)
- …activities to go live with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide ... and distribution network, and act as technical SME supporting next-level operational challenges with our internal and external partner operations.- This individual… more
- Merck & Co. (North Wales, PA)
- …not limited to global orchestration lead, manufacturing, supply chain, IT, legal/ compliance , market access, marketing, precision medicine, and field commercial. Lead ... to integrate INT operations into treatment sites, and address potential operational bottlenecks at sites, ensuring a smooth commercial ordering experience. Provide… more
- Formation Bio (New York, NY)
- …role, you will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the ... regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks ... Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General… more
- Bayer (Filer, ID)
- …and photoperiod control, automated irrigation setup, and integrated pest management (IPM). Manages daily GH activities, including germination and transplanting ... coaching and mentoring support to GH staff on the effective plant health management , data management and utilization of capacities, resources and processes.… more
- Merck & Co. (Rahway, NJ)
- …Data Analytics, Driving Continuous Improvement, Global Sourcing Strategies, Results-Oriented, Risk Management , Strategic Sourcing, Strategic Thinking, Supply ... execution of sourcing strategies and initiatives, and the relationship and performance management of strategic suppliers of MRO Services globally. You will work… more
