- Insmed Incorporated (NJ)
- …cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk ... risk assessments and develop mitigation strategies CSV Program Oversight : Oversee the CSV team, validation strategy and continuous process improvementEnsure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk ... reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management… 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 ... complex legal issues and provide sound advice Ability to proactively make business -intelligent risk assessments of various contract types, proposals, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …insights and intelligence to inform decision making & drives digitalization and business solutions to attain NNI goals. Finance & Operations works closely across ... core operations and develop insights to drive growth and operational excellence across the value chain while innovating for...facilities and assuring the integrity and completeness of all business transactions. At Novo Nordisk, you will have the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …BDM management and in collaboration with stakeholders that are optimized across business units, regions, and functional areas to ensure successful outcomes for ... skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, Direction, and Strategy: - In… more
- Insmed Incorporated (NJ)
- …Provide strategic leadership and decision making on CSV strategy using Insmed's risk -based approach. Provide oversight and manage multiple projects at the ... associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, ... QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resourcing for case processing. This role leads the Case Management Activities and oversight of case Intake, Triage and case processing. The role also involves ... oversight of Vendors and management of ICSR Verification teams,...Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports directly to Head of PV Case Management. This role involves the oversight of case handling activities across the locations. Collaborate with the other ... closely with Promotional Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team, fostering a… more
- Formation Bio (New York, NY)
- …development plans Medical leadership in the execution of clinical trials - risk assessment, operational considerations, safety and efficacy considerations as ... well as commercial needs. Medical monitoring and oversight of phase 2-4 trials Business Development: Provide medical input to business development candidates… more
- Insmed Incorporated (NJ)
- …and inspection readiness. The Sr. Quality Engineer will partner with IT, business , and vendor teams to apply risk -based approaches, maintain validated ... integrity, and electronic records/electronic signature requirements.Collaborate with IT System Owner, Business Owners, and validation teams to ensure risk -based… more
- Merck & Co. (Rahway, NJ)
- …clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a state of ... The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: Leading… more
- Insmed Incorporated (San Diego, CA)
- …and the development of assigned programs in alignment with Insmed's business needs.What You'll Do: Independently serving as the regulatory representative on ... cross functional teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as...to the VP of Regulatory Affairs and relevant teamsWith oversight from the VP of Regulatory Affairs, lead the… more
- Ally (Raleigh, NC)
- …a few days a week with some remote work. The Operational Risk Testing and Monitoring (T&M) Oversight Team is responsible for establishing enterprise-wide ... appropriate monitoring and testing coverage. The Operational Risk Senior Analyst will assist in the oversight...**The Skills You Bring** * 3+ years' experience in Risk Management or applicable line of business … more
- SMBC (Jersey City, NJ)
- … resilience and business continuity management. - Coordinates with 1st Line risk /resilience domains of operational risk , business continuity ... oversight of the 1st Line resilience programs - Operational Resilience, Business Continuity Management, Technology Resilience,...on a combination of technology risk management, business continuity management, and operational risk… more
- Ally (Lansing, MI)
- …that support both financial reporting and operational processes to foster a robust risk environment. The CFO Group Business Line Risk Senior Analyst will ... your opportunities be, too? **The Opportunity** The CFO Group Business Line Risk Senior Analyst will assist...operations, compliance, finance) to improve processes and ensure strong risk oversight * Coordinate and lead walkthrough… more
- HSBC (New York, NY)
- …and external audit and regulatory expectations + Anticipate, identify and mitigate operational risk in an appropriate, cost-effective manner + Ensure that ... challenging the adequacy of existing controls + Work with Risk Owners and other Business and Function...activities and processes are embedded into the SOX and operational risk frameworks + Continually drive standardization… more
- HSBC (Buffalo, NY)
- …a complex global environment + Experience of working with Operational Risk , Internal and External Audit + Excellent business writing, communication, ... Capital Management, Scenario Analysis Stress Testing processes for Strategic Risk + Engage and provide oversight of...for Strategic Risk + Engage and provide oversight of Material Change Initiatives, ensuring that the … more
- Tradeweb (Jersey City, NJ)
- …be responsible for performing vendor risk assessments and ongoing vendor risk monitoring and providing operational support.This role is key in supporting ... implement tools and automation that support effective management and oversight of vendor risk + Support vendor...relevant degree + 3-5 years' experience in vendor/third party risk management or operational supplier management, preferably… more
- Bentley Systems (PA)
- …for guiding the oversight and execution of Bentley's enterprise compliance risk management, global business resiliency, and crisis response programs. This ... risk assessments to identify risks and advise the business on risk prioritization and the execution...and SOX compliance teams to ensure alignment between controls, operational processes, and risk management objectives and… more
