- Insmed Incorporated (NJ)
- …to Executive Management and Boards of Directors .Strong understanding of risk management , compliance , and audit processes within regulated industries, ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic ... favorable debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutical Industry, Capital Project Management , Capital Projects, Change Management , Cybersecurity Risk Management , Data Analysis, Deviation ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality...operations (FLEx) and new capital builds, including automation lifecycle management , data/analytics, and site representation on capital projects.- Some… more
- Repligen (Waltham, MA)
- …years of hands-on experience in IT Audit, ITGC, or IT Risk Management within a public or large-scale company.Deep understanding ... are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness...This role drives the ITGC audit program, advises on risk mitigation strategies, and partners closely with Internal Audit,… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... and engage with the scientific community to influence the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …government reporting or departmental operational impact as assigned Responsible for ensuring that Compliance senior management is informed of compliance ... sciences, or relevant industry experience; 2+ years working in health care compliance or project management /coordination Strong knowledge and ability to… more
- Merck & Co. (Rahway, NJ)
- …escalation point for the docketing team, attorneys, and staffImmediately reports all risk management -related concerns to Senior LeadershipResponsible for the ... Office of General Counsel is seeking an Associate Director, IP Docket Management to provide docketing and legal operations support to the Intellectual Property… more
- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong ... Planning (MRP), Microsoft Power Apps, Portfolio Management , Procurement, Project Management , Risk Management , SAP Enterprise Resource Planning (ERP)… more
- Insmed Incorporated (NJ)
- …internal and external EH&S audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders on EH&S ... management systems, including documentation, standard operating procedures (SOPs), risk assessments, incident investigation protocols, reporting and emergency response… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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- risk taking ... trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),...philosophy-Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure … more
- Merck & Co. (Boston, MA)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... and mentoring special assignment partners. Primary Responsibilities: Partner with Oncology senior management and leaders to identify high-value strategic… more
- Merck & Co. (Rahway, NJ)
- …product development, such as manufacturing process development and validation, design control, risk management , material and molding, design validation to create ... with design verification, including but not limited to, design controls, risk management , materials & molding, process development and validation,… more
- Merck & Co. (Rahway, NJ)
- …cases to deliver enterprise value, focusing on innovation, risk , regulatory compliance , and scalability. Act as a senior technology business partner to ... Legal and Compliance Develop and support the practice of product management , building the mindset and practice of end-to-end accountability of product lifecycle,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and assist outside counsel as required Perform other duties as assigned by senior management Provide Corporate Law Legal Support Provide legal support and ... Finance, as directed by manager Collaborate work with various stakeholders, including senior management , other functions, and external counsel Stay updated on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all contracts are executed in accordance with company policies.- Develops and executes risk management strategies designed to protect DSI and DS Group and ... Summary: The is role is responsible for partnering with DS internal senior stakeholders to lead, assess, develop, negotiate and execute strategic sourcing activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance … more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Merck & Co. (Rahway, NJ)
- …communicate data-driven recommendations and findings to stakeholders at various levels, including senior management Collaborate with team members to define key ... Intelligence (BI) Desktop, Natural Language Processing (NLP), Python (Programming Language), Risk Management , R Programming, Science, Scientific Literacy, Trade… more
- Insmed Incorporated (NJ)
- …through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning.Monitors study metrics to ensure quality ... plans and documentation and provides regular study status updates to senior management .Manages vendors' adherence to contractual obligations including… more
- Merck & Co. (Rahway, NJ)
- …Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityUnder ... of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior Specialist will:Participate in the execution of financial, operational, SOX 404… more
