- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance function for the ... of MA risks identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on the obesity ... mitigate risks before scaling initiatives. Relationships Reports to the Executive Director of Strategic Operations. This position interacts with senior leadership… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supply Chain. Reporting into this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls, and Director - US R&D ... benefits and internal control related matters with heavy interface with senior management . Close interaction with the CVP of Corporate Accounting Services in Novo… more
- Merck & Co. (Rahway, NJ)
- …excellence in Compliance , Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also assist ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… more
- Merck & Co. (Rahway, NJ)
- …Data Management ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and ... Management Process, People Leadership, Product Lifecycle, Regulatory Affairs Compliance , Regulatory Affairs Management , Regulatory Communications, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …, Project Portfolio Management (PPM), Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement, Strategic Planning ... 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... products.Coordinate project planning, resourcing, progress reporting, troubleshooting and people management .Provide technical oversight of process development, process characterization and… more
- Eisai, Inc (Nutley, NJ)
- …agreements. May also audit operating systems, processes and procedures. May support risk management operations, including ongoing review of literature and ... product strategies. May plan and prepare report drafts for products, compliance statements, audit certifications, and safety issues for regulatory submission. May… more
- Merck & Co. (Rahway, NJ)
- …License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Currency Risk Management , ... International Trade Law, Investigative Skills, IS Audit, Legal Regulatory Compliance , Metrics Analysis, Process Improvements, Project Management , Project… more
- Merck & Co. (Rahway, NJ)
- … Compliance , Metrics Analysis, Problem Solving, Process Improvements, Project Management , Project Risk Assessments, Regulatory Affairs Management , ... IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Audits Compliance , Audits Compliance , Compliance Program Development, Crisis Management… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Management Process, Manufacturing Scale-Up, Process ... Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing...to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning… more
- Merck & Co. (Rahway, NJ)
- …prior to headquarters submissionManages regional programs (patient support, educational or risk management ) to support appropriate and safe utilization of ... Job DescriptionThe US Regional Director /Principal Scientist Medical Affairs (RDMA) is responsible for driving execution of the Value and Implementation (V&I) team… more
