- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead...projects when required.Support project teams in the resolution of performance issues if escalated at a regional level.Collaborate with… more
- Tris Pharma (Monmouth Junction, NJ)
- …of clinical study processes and procedures ensuring timely execution of quality clinical trials complying with all regulations and/or guidance. Collaborating ... have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and management of the resources within NACD. Relationships Reports to Snr Director of Clinical Strategy and Business Operations within Operational Excellence ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....industry best practices within capacity planning, reporting and overall performance metrics for clinical trial reporting Physical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... learn new indications required- Proven global line management expertise; experience of performance management and development of Director + level staff required-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …placement and delivery to US and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior Supply ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....bespoke, evidence-based M&A advisory services. Reporting into the Executive Director of M&A Advisory, the Director , M&A… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality ... Japanese, and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and … more
- Merck & Co. (Rahway, NJ)
- …operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational ... 2 years of management responsibility and experience developing staffFluency in the clinical quality management system and CMC process, across modalities and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... to safety guidelines Oversee daily activity for the group to ensure quality results performance management for direct reportsResponsible for Investigation and… more
- Eisai, Inc (Nutley, NJ)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... Neurology products, and will be responsible to deliver high quality and impactful models to ensure optimal patient access....all aspects of technical work as well as manage performance and ensure adequate training and support of staff.… more
- Merck & Co. (Rahway, NJ)
- …to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... continuous improvement initiatives to enhance data accessibility, usability, and performance .Stay up-to-date with emerging technologies and trends in information… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Tris Pharma (Monmouth Junction, NJ)
- …management planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to ... safety information updates, potential risks mitigation, etc. Collaborates with appropriate clinical , medical, quality and regulatory counterparts and others… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and ... as other research areas centered around rare diseases and immune disorders. SummaryThe Director of Oncology Imaging Science and Oversight will be a member of the… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
