- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and ... as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Merck & Co. (Rahway, NJ)
- …to lead /support regulatory GCP inspections.In this role you will: Lead Regulatory Compliance :-Develop and maintain GCP inspection procedures and ... for ensuring compliance with international standards and monitoring regulatory trends.Inspection Management:-Oversee the strategy for global GCP inspections,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts ... matters; Supports marketing in developing a commercial strategy include biomarker strategy ; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(GCO), develops strategy and provides oversight to all studies in compliance with internal processes and external requirements for the following areas in the ... in the remit of the SCBM group are activities to support GCO's compliance with DSI financial policies, investigator fee budget creation and review, oversight of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management and performance of CRO; Participates in creation of developmental and regulatory strategy ; Drafts protocol profiles and sections of key submission ... data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy , develops biomarker strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with CRO senior leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts ... matters; Supports marketing in developing a commercial strategy include biomarker strategy ; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy ...demonstrate that processes are in control and ensure required compliance levels. Implement and lead the process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes supporting global ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. This position has experience working on Phase I-IV study ... and/or pharmaceutical industry across multiple therapeutic areas and experience with regulatory submissions and inspections. Finally, this position has strong skills… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy , perform ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary In collaboration with assigned lead , responsible to assist in the accurate and timely administration and ... and identify strengths or anomalies to identify potential shifts in decision strategy as necessary. Make recommendations on potential process improvements to Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Monitoring.Responsibilities CRA Oversight and SME:Develop and implement a monitoring oversight strategy to ensure quality and compliance across the organization ... checks linked with CRA activities that require inclusion in the quality plan. Lead , participate, or support internal audit and regulatory inspection activities… more
- Eisai, Inc (Nutley, NJ)
- …management/senior leadership. Continuously update plans and inform stakeholders of progress.She/He will lead medical strategy mainly for GU oncology and provide ... from you.The Sr Medical Director provides medical leadership for medical affairs strategy , planning and supportive tactics mainly for GU therapeutic area. This role… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy ; Develops biomarker strategy ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- …execution, target product profile development, health authority interactions, global regulatory filing strategy , organized customer interactions, and market ... input on such activities as:target product profile (TPP) development, global regulatory filing strategy , launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …our alliance partner and internal cross functional team membersSupport the Global Asset Lead to develop the Integrated Business Strategy by actively synthesizing ... including product development team, target product profile development, global regulatory filing strategy , launch readiness reviews, organized customer… more
- Merck & Co. (Rahway, NJ)
- …for both people and project management and is accountable to set strategy for the delivery of high quality and compliant statistical analysis and ... vaccine programs.Interact with cross functional scientists including, Statistics, Clinical, Regulatory , QP2, CSRM, Data Management and Statistical Programming to… more
- Merck & Co. (Rahway, NJ)
- …changes and developments align with business requirements, industry standards, and regulatory compliance .Define and enforce change control processes and ... Within the EIT SAP Platform Team, the EIT SAP Integrated Delivery & Design Authority Lead will assume the crucial role of leading the SAP Design Authority. They will… more
