- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... innovative, science-driven portfolios with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to drive strategy and… more
- 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)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform ... around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will ... and Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and consistency within and across programs on an ongoing basis to ensure data quality and adherence to established coding conventions. In collaboration with ... resultant coded data . Proactively identifies potential risks to medical coding quality , integrity, and timelines for assigned studies and escalates issues to the… 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
- 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)
- …a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and ... Monitoring.Responsibilities:CRA Monitoring Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with applicable policies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from ... review teams as well as with business partners to achieve high quality and accurate labeling in support of business objectives.ResponsibilitiesPreparation of new and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data .Drug Development Strategy: Provides input to multiple aspects of ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Maintains oversight of DSI contracts that are ... partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in cooperation with Legal Department and PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects of ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... capture the full discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited to briefing documents,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems ... preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to end. Ensure ... during internal and external regulatory audits (including FDA, EMEA).Support coordination of data collection and trend analysis as requested by QA and Regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …finished drug product batches by collaborating with all functions (including Quality Assurance, Quality Control, Operations, Vein to Vein, Batch ... to process improvement initiativesCollaborate with deviation investigation owners and quality leaders to resolve batch release issues and non-conformances in… more
