- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for ... strategic and execution perspectives for Eisai. Reporting directly to the Executive Director , IT Security, Compliance, & Architecture, s/he is the Global IT… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Device Quality & Regulatory will play a pivotal leadership role within the organization, overseeing the quality ... combination products. This role ensures the highest standards of device quality throughout the product lifecycle, from design and development to commercialization.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsible to support PV Quality System audits at our company's Animal Health own sites/entities, CROs and system audits. Support to monitor all ... acquisitions and partners as required.Identify and report critical and major quality and compliance risks and gaps during audit activities.Ensure effective follow-up… more
- Merck & Co. (Rahway, NJ)
- …, risk management , stakeholder management , and supplier value management within these categories. The Associate Director IT Services Procurement will ... relationships with stakeholders which are oriented to meeting their business needs.Change Management - Adopt high quality change practices with customers and… more
- Merck & Co. (Rahway, NJ)
- …scientific rigor. Proactively identifying and escalating operational risks. Partnering with director -level management to develop and execute operational and ... Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and… more
- Merck & Co. (Rahway, NJ)
- …network to enable process and formulation development.- In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...innovative ways to achieve results.Nature and Scope of Position:The Director reports to the Executive Director of… more
- Merck & Co. (Rahway, NJ)
- …new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific ... to cross-functionally.-Displays collaborative approach in problem solving, governance, change management and appropriately synthesizes key business information to … more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …customer base, including Legal, Privacy, investigators, and divisionally aligned IT Risk Management Liaisons.Perform demand management and quality assurance ... Job DescriptionThe Director of Cyber Threat Detection & Incident Response...and ensuring alignment with the budget.Ability to perform demand management and quality assurance functions to meet… more
- Merck & Co. (Rahway, NJ)
- …Sciences & Clinical Supply. The ideal candidate should have strong project management skills and a demonstrated commitment to operational excellence, with an ... of Drug Substance development, Drug Product development, Clinical Supply management or Analytical Research is critical for understanding business opportunities,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionA fantastic opportunity has arisen for an Associate Director Asset Management & Reliability CoE.Reporting to the Director , Asset Management ... in this role as Associate Director Asset Management & Reliability CoE, you will be responsible for...Analysis.Understanding of key business performance measures related to functional, quality , and cost issues.As a company, we are committed… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Merck & Co. (Rahway, NJ)
- …value evidence strategies for in-line and pipeline products. Obtain senior management approval of value evidence generation plans. Provide outcomes research ... presentations, and publications.Responsible for study-related contracting, budgets, and vendor/partner management .Develop American Managed Care Pharmacy (AMCP) dossiers for US… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical ... capacity and capability. The candidate will also partner with Bioprocess, Quality , and interdivisional stakeholders to grow our relationships with selected vendors… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including ... and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence (PVRI) and dissemination across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... readiness, cutover planning and execution, and post-go-live supportAdvocate change management within CSPV department by assessing org impact, proactively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as achieving overall project level quality metrics. An ideal Associate Director , Program Management must have the expertise and leadership to manage ... areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and proficient in creation of process maps preferredExperience working with Quality Management systems preferredExperience with requirements related to global ... Director , Development SOP Management Join a...Authorship and Review Maintain a close working relationship with Quality Assurance and participate in the Company Global SOP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and ... functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategize and plan for FDA meetings as needed. Acts as… more
