- Eisai, Inc (Nutley, NJ)
- …project managers, line managers, clients and other stakeholders.Job Summary:The Associate Director , Global Alzheimer's Disease Project Management is responsible ... the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management . Reviews status of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global QMS, QMS (GMP-QA).Ensure ... centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV...foster a culture of compliance and accountability in data management practices. The position also involves risk -based… more
- Eisai, Inc (New York, NY)
- …agreements. May also audit operating systems, processes and procedures. May support risk management operations, including ongoing review of literature and ... and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director , GCP Quality Assurance works within the Global Clinical Quality team… more
- Merck & Co. (Rahway, NJ)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards ... in fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (Rahway, NJ)
- … ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, partnering ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...)- - Internal & External Stakeholder Engagement and Change Management for Regulatory Data Standards - - The complexity… more
- Formation Bio (New York, NY)
- …Keeps management current on project status and provides ongoing risk assessments. Develops and implements continuous improvement processes for document writing ... bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a fast-paced environment, continuous improvement, project management , change management , and risk management . Responsibilities: Leadership, Direction, ... areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery… more
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... the assigned program(s) (ie Bulk Drug Product).--Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... trials and submissions work.Proactively identifies and manages risks for the data management function and supports functional risk identification/ management … more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... ensure effective implementation and cross-functional engagement. Position Description: The Director of Commercial Strategy will support strategy development for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of ... end-to-end: understanding predisposing non-clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product safety team in critical areas such as individual case medical review, risk management , aggregate safety reports, and translational medical safety. This ... May directly manage complex safety issues related to individual case review, risk management , translational medical safety, and aggregate safety reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of medical accountability and oversight for one or more clinical trialsMatrix management responsibilities across the internal and external networkManages Phase 1 -… more
