- Novo Nordisk Inc. (Plainsboro, NJ)
- …us? The Position The purpose of the Enablement Adoption & Governance Lead is to drive workflow optimization, streamline processes, reduce inefficiencies, and enhance ... systems, and processes. Relationships The role of the Enablement Adoption & Governance Lead reports directly into the Next Gen Customer Engagement and Enablement … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Merck & Co. (North Wales, PA)
- …data capabilities and data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data value chain including but ... Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of these Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Leadership: Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... involve ICF, CRF guidelines, IB and safety communications, DSUR, IND. Lead the CRO and vendor selection process...management of CRO(s) and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … function, providing strategic direction and ensuring alignment with organizational goals. Quality and Compliance Oversight: Lead and/or participate in ... Oversee and or participate in internal audit programs and lead IS quality audits to ensure regulatory compliance and successful outcomes. Participate in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … vendor budget and activitiesOversee the quality and timeline of vendor workCollaborate with study medical lead and biostat to ensure availability of ... manuscripts, abstracts, poster presentations, and oral presentations related to the brand(s).Manage vendor budget and activities and oversee the quality and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with stakeholders to ensure a compliant ready state of operation.Ensure that CRO/ Vendor quality events/ incidences are adequately reviewed and CAPAs followed up ... a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory... Quality leadership team c. Develop/ chair or co- lead quality council as necessary.Ensure the vision… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works closely with Manufacturing and Quality Control to resolve ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …list of congresses that would best support the company and brand objectives.- Lead planning and execution weekly meetings with Global and/or National Congresses key ... corporate awareness.- Drive collaboration and partnerships between DS Regional Congress lead (DSE, DBR ) to align on expectations, ensure global participation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activity related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of ... for statistical programming practice, especially with respect to oversight of vendor performance. Oversees compliance with standard procedures and processes.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of data at Daiichi Sankyo including: the stewardship organization, data quality , metadata management, lineage capabilities and the data governance processes ... including advocating for good data governance, stewardship, data identification, and data quality to enable business outcomes. This role will consist of these… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …following high quality standards to meet patient needs. Responsible to lead the activities related with stability studies program performance in accordance with ... rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to… more
- Merck & Co. (Millsboro, DE)
- …at our company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as applicable to the ... (IACUC), and facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination with other… more
- Merck & Co. (Durham, NC)
- …procedures to resolve process/equipment issues, minimize downtime, and ensure product quality .- This role actively supports, participates, and embraces an inclusive ... team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required. Primary activities for this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally ... collaborative studies. Ensure projects align with strategic goals and compliance standards from initiation through completion.Operational Strategy: Develop and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... providers to deliver R&D information applications solutions. Establish strategic vendor management relationship and governance. Responsible for Strategic Application… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is role is responsible for partnering with DS internal senior stakeholders to lead , assess, develop, negotiate and execute strategic sourcing activities (both US and ... Leads all aspects of strategic sourcing to ensure best value (cost, quality , Account Mgmt, timelines) for the businesses. Performs in-depth bid analysis and… more
- American Honda Motor Co Inc (Marysville, OH)
- …to Bring the Future!Job PurposeThe role of a Data Analytics Team Manager is to lead and manage a team of data analysts and/or data scientists in extracting insights ... Collaborate with data scientists or statisticians to develop robust analytical models.Data Quality and Validation: Ensure the team follows best practices for data … more
- American Honda Motor Co Inc (Marysville, OH)
- …preventative maintenance, and inspection technologies) and act as liaison to vendor (s) to optimize and standardize joining equipment.Meet requirements of new model ... development and maturation (parameter development, destruct/countermeasure, quality standard sheets, drawing review, feasibility studies, and build support) to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ability to balance needs spanning customer service, operations, marketing and compliance . Relationships This role reports to the Associate Director-Patient CRM ... with external service providers and technical development vendors. Essential Functions Lead the strategic implementation of bespoke telephony and Salesforce CRM… more
