- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration:Facilitate effective communication and collaboration with internal stakeholders, including IT and Compliance Risk Management as well as Global ... culture of compliance and accountability in data management practices. The position also involves risk -based...PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art… 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)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... Data Management globally and ensures execution of the global data management strategy across regions and across studies/programs. Lead DM resource model… 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 ... alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance and inspection preparedness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in a fast-paced environment, continuous improvement, project management , change management , and risk management . Responsibilities: Leadership, Direction, ... levels and from different disciplines and cultures. This position requires demonstrated line management experience and the ability to manage/ lead people and a… 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 ... rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function… 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 ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… 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)
- …ensuring all contracts are executed in accordance with company policies.Develops and executes risk management strategies designed to protect DSI and DS Group and ... role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate, and execute strategic sourcing activities (both US and… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Enterprise Risk Management (ERM), Environment Management , External Collaboration, Fast-Paced Environments, GMP Compliance , High Resolution ... of 8 years of relevant work experienceProven track record of successful project management , encompassing resource management , risk assessment and mitigation… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products globally.- Experience in design controls, device risk management , medical device, complex combination product kits, prefilled ... picture, and how activities link to our Company strategy and business goals- Utilize device risk management tools to build device or combination product risk … more
- Merck & Co. (Rahway, NJ)
- …global filing and launch strategy, long-range demand vs capacity planning, integrated risk management , cost of goods projections, and post-approval product/ ... technical changes, robustness/quality/ productivity projectsManage product supply chain Integrated Risk Management (IRM) and Business Continuity Planning (BCP),… more
- Merck & Co. (Rahway, NJ)
- … goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... for establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management .--The Associate… more
- Merck & Co. (Rahway, NJ)
- …Development Sciences (RaDS) value team in R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line....experience researchers, engineers, and data scientists to assess value risk , usability risk , feasibility risk … more
- Merck & Co. (Rahway, NJ)
- …Sciences (RaDS) value team in our Company R&D IT brings together product management , engineering, and data science expertise. We enable data, technology and services ... RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line....experience researchers, engineers, and data scientists to assess value risk , usability risk , feasibility risk … more
- Merck & Co. (Rahway, NJ)
- …, Project Portfolio Management (PPM), Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement, Strategic Planning ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.-...program(s) (ie Bulk Drug Product).--Oversees all bulk drug supply management and ensures proper allocation of drug product as… 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)
- …timely and accurate information and status updates to project sponsors and management .Champion compliance and safety; promote a culture of diversity, inclusion, ... cell bank process performance across programs, support timeline creation and management of work packages within project teams. Monitor and project resource… more
- Merck & Co. (Rahway, NJ)
- …programs.Technical scope:Direct projects focusing on cell bank process risk assessments, documentation, process characterization, technology transfer and ... and sustain technical standardization of best practices across the network. Lead assignment execution against accelerated timelines, in a right-first-time manner,… more
- Merck & Co. (Rahway, NJ)
- …Teamwork, Decision Making, Drug Development, External Manufacturing, GMP Compliance , Innovation, Management Process, Manufacturing Scale-Up, Process ... to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable of discerning...others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in… more
