- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with ... and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical ...but not limited to SCORE, DRF - Create a performance -based team culture with clear accountability and a sense… more
- Merck & Co. (Rahway, NJ)
- …Has a deep understanding of multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …(include Requirements For Education, Experience And Skills)Job Description:The Associate Director Quality Assurance, Facilities, Validation & Automation will ... Director of Facilities and Validation.Primary ResponsibilitiesResponsible for providing quality assurance support and oversight for commissioning/qualification of the… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management, development ... of these objectives. This position will report to the Sr. Director , Group Leader, GPM&L. Responsibilities Project Responsibilities: Independently manage and drive… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; ... TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… 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....ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with ... & Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan… more
- Merck & Co. (Rahway, NJ)
- …and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical Research, ... role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies… more
- Catalent (Harman, WV)
- …and applicable regulatory SOP and cGMP guidelines.Manages processes to optimize quality performance and on-time delivery to insure customer ... Senior Director , Supply Chain Position Summary: The Senior ...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Merck & Co. (Rahway, NJ)
- …and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and reporting.Direct the activities of programmers whose ... and vaccine programs.Interact with cross functional scientists including, Statistics, Clinical , Regulatory, QP2, CSRM, Data Management and Statistical Programming to… 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)
- …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
