- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA and brand activities. Secure global funding and assess progress during pre-launch Risk Management : Proactively raises risks within the brand/launch plan to ... ready to experiment with us? The Position The Associate Director - Launch Operations will play a pivotal role...individual will have a proven track record in program management , coupled with expertise in launch excellence methodologies and… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA and brand activities. Secure global funding and assess progress during pre-launch Risk Management : Proactively raises risks within the brand/launch plan to ... ready to experiment with us? The Position The Executive Director , Head of Launch Excellence will play a pivotal...structure to support new launches and market readiness Budget Management : Work closely with finance and brand strategy to… 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
- 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)
- …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)
- …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)
- …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)
- …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)
- …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
- Merck & Co. (North Wales, PA)
- … ( RDM) Strategy & Regulatory Data Standards Governance- - Regulatory Compliance and Risk Management for Regulatory Data - Direct and Indirect (eg, partnering ... Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable...)- - Internal & External Stakeholder Engagement and Change Management for Regulatory Data Standards - - The complexity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for overall product safety strategy or specific areas of safety surveillance and risk management , and provide safety leadership including but not limited to ... topics, and regulatory submissions. This individual will ensure proactive safety monitoring and risk management through the Safety Management Team framework.… 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
- 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
- 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
- Merck & Co. (Upper Gwynedd, PA)
- …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. (North Wales, PA)
- …preparing for numerous potential launches of our medicines and vaccines. As Associate Director , Launch Excellence, you'll play an important role in preparing for and ... and cross-functional interdependencies across all launch workstreams.Lead scenario planning, risk assessments and prioritization of critical launch activities.-Create end-to-end… more
