- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk's overarching global ethics and compliance program. Relationships Reports to the Executive Director , Risk Insights & Management . Manages a team of ... 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)
- …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
- 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)
- …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)
- …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)
- …Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional ... units and corporate functions.Lead Training function team and Document and record management function team to enhance training and document and record management … more
- Merck & Co. (Rahway, NJ)
- …of critical strategic initiatives, ensure alignment, drive continuous prioritization, and support risk management as neededEngage with program leaders to drive ... Organizational Change Management , Organizational Changes, Personal Initiative, Project Management , Readiness Assessments, Risk Management , Risk… 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 ... business implications are accurately accounted into strategy management processes. Relationships Reports to the Vice President - US Operations Strategy. Internal… 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
- 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)
- …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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... years direct or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA… 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)
- …ultimately negotiated with PBM/payer customers. Relationships Reports to the Executive Director , Strategic Pricing & Contracting. Responsible for leading a team of ... to customers o Provides regular updates for Brand Teams and Senior Management on contract performance issues, including over- and under-performing contracts o… more
- Merck & Co. (Rahway, NJ)
- …Ethical, resilient, and committed to scientific and operational excellence Skilled in risk management , team facilitation, and strategic planning Experience in ... 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… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative ... with a focus on quality and documentation.Skilled in change management and guiding teams through transitions.Excellent communication and cross-functional… more
