- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high- quality clinical regulatory documents while adhering to regulatory guidelines....and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study ... decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and interpersonal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust data governance ... test, audit and validate HR data to maintain high data quality standards.Conduct system audits, optimize performance, and troubleshoot technical issues.Develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best ... practices at cross-functional meetings. Assists in the development of Standard Operating Procedures (SOPs) and process improvements. Follows agreements with external partners.Department Coordination: Builds cross-functional and cross-regional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior ... CMC Lead regarding the activity status and potential critical issues, or to the governance bodies. Responsibilities - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr CMC Lead is established, take… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO/vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business partnership with the global business and Global IT functions at Daiichi Sankyo. As a trusted partner, provide… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting documents and evidenceSupport with implementing and ensuring global DBMA quality standards for Change requests IT Vendor Oversight and ManagementManaging ... all data requests, perform self-QC of data to ensure quality of results. Service Provider Oversight & ManagementOversight of...usual.Leads or assists in the tracking and investigation of quality and compliance issues OtherReview and update of DMA… 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 ... to develop and deliver processes, training, procurement technology and knowledge management tools. Closely partners with senior Business stakeholders to design optimal processes and sourcing solutions that meet the business' objectives and produce synergies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Howmet Aerospace (Dover, NJ)
- Howmet Engine Systems (HES) seeks a highly qualified Associate Quality Director . They will be sharing the responsibility for all aspects of Quality for ... and functioning system of checks and balances that facilitate operations. The Associate Quality Director will assist the Business Unit (BU) by interfacing… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . Position Summary The Associate Director , RBQM - HOCT, ICN will mainly be responsible ... for developing the Quality Narrative at the study and/or ASSET and TA...TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk… more
- Bristol Myers Squibb (Summit, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , RBQM - HOCT, ICN will mainly be responsible for ... developing the Quality Narrative at the study and/or ASSET and TA...TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk… more
- Bristol Myers Squibb (Summit, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director , Therapeutic Area Audit Strategy Lead will be ... R isk, G overnance, O perations (RGO) in the development of the Quality Narrative, specifically developing and contribution the audit/inspection portion . + Apply a… more
- Bristol Myers Squibb (Summit, NJ)
- …than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to Contract ... This role will partner cross functionally with Global Product Quality (GPQ), External Manufacturing (ExM), Manufacturing Science & Technology (MS&T/CTTO),… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology, Prostate Cancer** As a ... member of the US Medical Affairs Oncology team, the Associate Medical Director , Prostate Cancer will support...Cancer will support the development and execution of high quality US medical strategy for the tumor type(s) and… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , Statistical Programming, provides functional expertise and ... of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative… more
- Metro YMCA of the Oranges (Maplewood, NJ)
- Associate Director of School Age Childcare South Mountain YMCA, 13 JEFFERSON AVE, MAPLEWOOD, New Jersey, United States of America Req #1734 Tuesday, January 7, ... SUMMARY: Under the general direction of the Director of Youth Development, the Associate Director of School Age Child Care is responsible for the daily… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there's only one choice.** ** Associate Director , Market Access Data Specialist** ** Associate Director ... , Market Access Data Specialist - Commercial Data Solutions** The Associate Director , Market Access Data Specialist is a member of Bayer's growing Commercial… more
