- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead (s) (GQLs) and Regional Quality Leads (RQLs), who are ... and external cross-functional meetings or other relevant activities.Support the External Partner Quality Lead (s) (EPQLs), who are responsible for delivering and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of external data -- acceptance, storage, and delivery activities to ensure complete, high- quality data is available for use by clinical study teams in a ... to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role....and other initiatives. Proactively identifies and manages risks to data quality , data integrity, programming… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of ... matters. Responsibilities:Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …process capability to ensure processes are robust and continuously improving. Work with the Data Management and Integration Lead and Process Validation lead ... Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team...and manufacturing operations.Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processesAbility to… more
- Merck & Co. (Rahway, NJ)
- …to create needed assets, or enacting internal initiatives.Leads team in conducting data innovation analytics including data quality assessments, ... providers.- ` Qualifications: Overall, proven ability to build a data asset strategy & innovation agenda and lead... data asset strategy & innovation agenda and lead its execution.Strong business acumen with a keen ability… more
- Merck & Co. (Rahway, NJ)
- …is a plusTranslate use cases into implementation roadmaps to deliver high quality data productsEstablish common performance expectations and processes for ... role, you will be part of the HHDDA Commercial Data Solutions team and lead Digital Product...shape the overall staffing strategy and continuously ensure high quality deliverables and optimized return on investment for the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to RBQM CSM to improve quality and ensure patient safety and data quality and integrity.Establish, measure, analyze and report on RBQM CSM related ... process improvement, metrics design and application and other key drivers of enhanced quality .Aligns with the RBQM Risk Management Lead on critical-to- quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, GMP QA Process Excellence is accountable to collect information, analyze quality related process, define strategies to lead to the development ... working closely with local, regional and global stakeholders across the Quality Assurance organization and with members from different business functions and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction ... protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....developing others is required - shown ability to indirectly lead and direct teams We commit to an inclusive… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …incorporating relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust ... and processes. This position will act as the functional lead with technical and operational expertise across multiple HRMS...privacy.Implement processes to regularly test, audit and validate HR data to maintain high data quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …metrics.Implement and manage robust data governance processes to ensure ongoing data quality and security, facilitate or collaborate in regular audits ... support materials for end-users, handling of queries, troubleshooting, and quality control. Lead or support consulting and implementation...with data governance processes to ensure ongoing data quality and security, supported by regular… more
- Aequor (New Brunswick, NJ)
- …the required processes and tools to evaluate performance and enable proactive data -driven risk detection and decision-making. Lead the development of GSC pillar ... E2E planning, clinical supply chain, process and digital excellence).Driving data analytics and visualization strategy by collaborating with business partners… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will interface with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance… more
- Formation Bio (New York, NY)
- …and documentation to ensure the consistent production of safe, effective, and high- quality pharmaceutical products. Lead internal and external audits to assess ... bring new treatments to patients faster and more efficiently.About the PositionThe Director, Quality Management Systems plays a pivotal role in ensuring quality ,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance ... complies with all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across the RA function… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position will lead the valuation processes for in-licensing, out-licensing, co-development and/or acquiring ... assessments consistent with our corporate business development strategy. This position may lead a small team and will report to the Head of Forecasting/Business… more
- Tris Pharma (Monmouth Junction, NJ)
- …Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) ... supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality ...(OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs Performs in-depth data analysis to identify compliance concerns, root causes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders.SummaryThe Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall ... commercialization).ResponsibilitiesDepending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians and… more
