- Merck & Co. (Rahway, NJ)
- …E, Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and ... ensuring regulatory compliance while advancing the credit union's payments strategy in alignment with its growth objectives.Key Responsibilities:Develop and execute… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy , Design Controls(Associate Director Equivalent) Our company's Device ... projects.Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic ... innovative product launches and launch excellence within our US Market Strategy organization. We are dedicated to improving lives through human-centered healthcare… more
- Merck & Co. (Durham, NC)
- …at the Vaccine Manufacturing facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management, and growth of our ... high degree of accuracyStrong analytical and problem-solving skills.- Strong risk -based decision-making skills.A positive, collaborative, consensus building approach to… more
- Repligen (Waltham, MA)
- …internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the organization and ... in support of the ISO 9001 standard.Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation when required. Review and approve New Product Development Design History Files for the site.… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management, human factors, technical integration, assembly automation, etc.), as well ... manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. ... across different disease areas, and the ability to determine risk factors with and for other technical departments (eg,...the RBQM space is also required. Responsibilities: - Group strategy : Sets the vision and strategy for… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy , lead activities, and develop a team whose roles include design and ... Biologics and Biopharmaceutics leadership and extended leadership teams to implement strategy , conduct scientific research from the laboratory to commercial scale,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned with the company's strategy ... trending and signal detection is communicated to stakeholders for risk mitigation.Support the stakeholders in identifying and defining quality improvement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development and execution of a ... unified LinkedIn strategy that spans multiple regions, ensuring it aligns with...policies, monitoring trends and working cross-functionally to ensure the risk to Daiichi Sankyo is minimized.- DAIICHI SANKYO SOCIAL… more
- Merck & Co. (Rahway, NJ)
- …closely with other functional area representatives to negotiate timelines and strategy for clinical supplies . - Interacts with key partner organizations ... company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain...with facts and data - Demonstrates ability to balance strategy with ability for tactical execution and has strong… more
- Merck & Co. (Rahway, NJ)
- …closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.-Interacts with key partners in both GCS (Logistics ... projects, etc.)-Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence… more
- Eisai, Inc (Nutley, NJ)
- …insights, building Eisai's capabilities in Data Driven Decision Making aligned to brand strategy and investment priorities. In this role, you will be responsible for ... shaping our Advanced Analytics and Omnichannel Analytics strategy , budget planning by therapy area, ensuring the appropriate integrated omnichannel promotion … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and ... continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely… more
- Merck & Co. (Upper Gwynedd, PA)
- …including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project ... regulatory strategy (ies) by ensuring robust assessment of global regulatory CMC...communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership as needed… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center, powered by insight and foresight. We develop an end-to-end approach to strategy , focusing on every touchpoint that impacts our customers. We leverage data ... insight generation. Drive a robust actionable insights plan for informing portfolio strategy and prioritization in collaboration with the portfolio strategy … more
- Insmed Incorporated (San Diego, CA)
- …guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support ... of vendors for potential use and provides direction, guidance and strategy for company Quality Assurance.Full understanding of and practical experience establishing… more
- Merck & Co. (Rahway, NJ)
- …to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.The successful candidate will play a pivotal role ... candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing… more
- Merck & Co. (Rahway, NJ)
- …leader to shape and drive innovation across the Biologics pipeline, strategy , and science.Anticipate and solve scientific and technical challenges across projects ... to strategic initiatives; work with senior leaders to establish overall project strategy and guide teams in its execution.Conceptualize, plan, and execute projects… more
