- 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)
- …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)
- …ensuring the quality of PM activities including: communication, planning and management of schedule, budget, scope, issue risk management , and quality ... and Corporate Functions. They are responsible for ensuring consistent and effective management of approved Global and Regional IT projects and optimized PM resource… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF… 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)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for producing scientifically ... accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP ... relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust data governance… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to drive data excellence and enhance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead… more
- Merck & Co. (Rahway, NJ)
- …Technical Operations,-Single Use Technology, or Sterile Operations.Strong project and time management skills to facilitate on-time delivery and quality ... Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global...the implementation of the business solution using the Capital Management stage gate process with varying degrees of responsibility… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational ... projects to ensure homogeneity within IT and supports oversight and management of integrations solution design, implementation strategy and requirements gathering,… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global) for given commodities/business areas and leading the overall supplier relationship management program for DSI, for DS products and alliances. Cultivates a ... responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a detail-oriented Associate Director of Consolidation Accounting, tasked with the role of overseeing the accurate and timely ... enhancing their business acumen for future opportunities.Reporting directly to the Director of Consolidation Accounting, this role is integral to our financial… 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
