- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision ... pharmaceutical industry across different disease areas, and the ability to determine risk factors with and for other technical departments (eg, Clinical, Medical,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Business owner for ALTOS global system following governance modelLead training related risk analyses and escalate them to senior leadership in GQAResponsible for ... development, oversight, and maintenance of GQA training programs to ensure cross-functional transparency and consistencyEnsure necessary support is provided to QA functions to develop training curriculums and conduct them in line with the overarching training… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable ... stakeholders to streamline the product lifecycle process and develop risk mitigation strategies.Provide comprehensive quality oversight and strategic quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process ... from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director , Laboratory Data Management is accountable for the end-to-end delivery of ... fast-paced environment, continuous improvement, project management, change management, and risk management. Responsibilities: Leadership, Direction, and Strategy: - Establishes… 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 ... at the site level to ensure that patient safety with respect to the safety risk assigned remains top of mind in the context of patient management in the clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... safety team in critical areas such as individual case medical review, risk management, aggregate safety reports, and translational medical safety. This role requires… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in continuous improvement, project management, change management, and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with ... manages risks for the data management function and supports functional risk identification/management efforts globally.Serves as the internal Data Management expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful implementation of studies. ... according to the agreed project plan. Complete a study risk assessment and ensure mitigation and contingency measures are...DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overarching global ethics and compliance program. Relationships Reports to the Executive Director , Risk Insights & Management. Manages a team of compliance ... and mitigate identified ethics and compliance risks as part of NNI's risk management program. This role leverages innovative technology, data analytics and data… 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 ... position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is ... focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff to… more
- Merck & Co. (Rahway, NJ)
- …As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing ... every aspect of our business processes, systems, and data.The Associate Director will collaborate and interact with cross-function teams to identify opportunities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic ... are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations, you will lead the enterprise… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Management Improvement, Project Planning, Project Risk Assessments {+ 5 more}-Preferred Skills:Job Posting End Date:06/24/2025 ... *A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R353108 more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... analysis, and documentation of cell culture process commercialization Drive risk assessments, control strategies, comparability reports, PPQ, and regulatory… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …plans to drive growth and longer-term value. Close collaboration with the Director of Enterprise Strategy Activation is essential to ensure strategic shifts and ... strategic coordination across Novo Nordisk. Partners closely with Associate Director - Enterprise Strategy Activation. External relationships may include interactions… more
