- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key internal and external ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- 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)
- …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)
- …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. Establishes… 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)
- …meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval ... of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.ResponsibilitiesDevelop and implement US regulatory strategy for assigned project(s).Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and… 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)
- …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)
- …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)
- …, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …cross-functional team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management ... research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , Program Management is a senior position responsible for… 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
- Kean University (Union, NJ)
- …other supporting documents you may wish to submit.** **Office of University Relations** Associate Director of Multimedia Under the direction of the Director ... of Multimedia Production and Strategy, the Associate Director of Multimedia ( Associate Director ...the coordination, shooting and editing of news videos, ensuring high- quality storytelling that aligns with the university's goals and… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the... of data is suitable for regulatory submission. The Associate Director will have routine interaction with… 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
