- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you.The Director , Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio ... IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish… more
- Merck & Co. (Rahway, NJ)
- …development of procurement strategy, global and regional category management , contract management , risk management , stakeholder management , and ... with the business and regions.Process - Realize sourcing management , supplier value management , risk management , supplier diversity and SAP as core… more
- Merck & Co. (Rahway, NJ)
- …study concepts and protocols Manages regional programs (patient support, educational or risk management ) to support appropriate and safe utilization of Our ... Job Description Role Summary: The Regional Director Medical Affairs (RDMA) is responsible for driving...well as oral) skills, in addition to results-oriented project management skills Preferred: Scientific leadership and other key stakeholders… more
- Merck & Co. (Rahway, NJ)
- …communicate the importance & urgency for early LDL-C treatment for Cardiovascular Risk Management .Embed patient insights within the commercial perspective across ... communicate the importance & urgency for early LDL-C treatment for Cardiovascular Risk Management .Embed patient insights within the commercial perspective across… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …internal customer base, including Legal, Privacy, investigators, and divisionally aligned IT Risk Management Liaisons.Perform demand management and quality ... Job DescriptionThe Director of Cyber Threat Detection & Incident Response...diverse internal customers, including Legal, Privacy, investigators, and IT Risk Management Liaisons.Program Management :Experience in… more
- Merck & Co. (Rahway, NJ)
- …filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an ... 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… more
- Merck & Co. (Rahway, NJ)
- …regulatory requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and ... Job DescriptionThe Executive Director , Device Quality & Regulatory will play a...Part 4).Lead quality oversight of product validation, verification, and risk mitigation activities.Regulatory CMC OversightLead the preparation and submission… more
- Merck & Co. (Rahway, NJ)
- …Development. -The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit ... 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)
- …the planning of PV Audit training sessions, and compilation of PV Audit Risk Assessments (eg, for Supplier Qualification)Support our company's Animal Health sites in ... frequent field alerts, recalls, rejects and complaints.Support in informing Senior Management of emerging regulatory and PV trends to help avoid compliance… more
- Merck & Co. (Rahway, NJ)
- …and leadership skills.Project management experience including resource management , budget forecasting, and risk assessment/mitigation planning.Comfort with ... Job Description Job Description: Director (M3), Analytical External Capabilities, Validation & Compliance (ECVC).The selected candidate will work in the Analytical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global PV regulations for individual case safety reporting, periodic reporting and risk management . Develops and implements strategic initiatives for global ... around rare diseases and immune disorders. Summary Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts including… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to develop and implement security solutions and capabilities through application of risk management methods to information technology in order to manage ... areas centered around rare diseases and immune disorders. Summary Director Solutions Architect, Information Technology position will strategically assess...IT risk . Ensure DSI's Cybersecurity readiness capabilities.- The position is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical ... with the PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1-3… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current clinical practice ... this position works with other CSPV staff and cross functional Safety Management Team (SMT) members, often handling straight-forward CSPV tasks such as single… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network, Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... studies.Partners with Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations, standards and… more
