- 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)
- …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
- 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)
- …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)
- …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
- 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)
- …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
- 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)
- …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
- 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 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)
- …Lab Lead will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and ... internal resources and academic or industrial partnerships.- In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a… 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)
- …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)
- Job DescriptionAs the Director /Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the ... Director of Device Regulatory Affairs for Autoinjector Development Programs....accuracy and completeness of submissionsPartner with Device Development, Device Quality , and other Drug stakeholders to communicate and align… 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)
- Job DescriptionThe Associate Director Data Science will be responsible for developing and communicating data-driven and actionable insights that drive greater ... strategiesBe accountable for ensuring delivery of analyses with high quality standards, timeliness, compliance, and excellent user experience (routinely keep… more
