- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The senior director will ensure a strong focus on competencies supportive of project management ; vendor management and stakeholder management . At this ... compliance with all Company and Regulatory requirements.Work with outsourcing procurement management to optimize the vendor governance structure, incorporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... destruction of investigational products with approved vendors and obtains required documentation. Vendor Management -supports Person in Plant (PIP) activities… more
- BioAgilytix (Durham, NC)
- …Lab Operations, and external vendors.Pragmatic problem solver with risk-based prioritization, vendor /contract management experience, and a bias for automation ... life-changing, life-saving therapeutics to the patients who need them.The Cybersecurity Lead will be responsible for building and leading BioAgilytix's global… more
- Merck & Co. (Rahway, NJ)
- …Continuity Planning (BCP), including identification & prioritization of mitigation strategies. Lead Global Filing and Launch (GFLS) strategy development to ... manufacturing operations, technology, quality, and supply chain.- Proven ability to lead global , cross-functional teams through complex strategy/ project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Process for the respective business areas.Responsibilities:Leadership and Project Management : Lead the end-to-end quality execution across Medical Affairs ... collaborating with GxP Quality representatives across the organization Quality Management and Continuous Improvement: Lead effective communication efforts within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including root cause analysis and ... Call Center, Product Quality/Technical Complaints, Patient Safety Organization Call Center Vendor . Provides support and escalation channels for both internal teams… more
- Insmed Incorporated (San Diego, CA)
- …Affairs and relevant teamsWith oversight from the VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans ... as the regulatory point of contact for interactions with FDA and other Global health authoritiesAssist/ Lead communications with FDA and with other Health… more
- Merck & Co. (Rahway, NJ)
- …data ingestion patterns and data quality standardsLeads data contracting and vendor management for strategic data partners across HHDelivers integrated ... mitigation strategies and represent a Digital/ Analytics org in Legal, Privacy, and Global Ethics forumsAble to lead large and high performing cross functional… more
- Eisai, Inc (Nutley, NJ)
- …contact for Eisai's US monitoring activities, managing in-house efforts and third-party vendor engagements. The Associate Director will also play a critical role in ... analytics to enhance operational efficiency. The role includes direct people management responsibilities and will contribute to the development and implementation of… more
- Eisai, Inc (Nutley, NJ)
- …of that plan.Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal audit ... is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and... management system.Direct and oversee operational and budget management , vendor management , development &… more
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