- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Forecasting Product Success will work within the Human Health Digital, Data, and Analytics (HHDDA) division where we are realizing ... to propose, prioritize, and evaluate new product featuresDeveloping and executing quality assurance plans to ensure the configured product meets business… more
- Insmed Incorporated (New York, NY)
- …competitive pipelines and lifecycle plans, medical and pharmacy benefits, quality programs, etc.)Committed to self-improvement.Travel RequirementsUp to 80% domestic ... travel; some of which will be overnight in natureSalary Range200000-239600Compensation & BenefitsWe're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- 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
- Merck & Co. (Rahway, NJ)
- …new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific ... and ethical standards.-The Distinguished Scientist (Executive Director ) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary… more
- Merck & Co. (Rahway, NJ)
- Job Description Associate Director - Global Oncology New Assets DescriptionThe Associate Director of Global Oncology will be a role responsible for ... organizational and collaborations skillsMust be able to deliver high quality results under tight timelinesHigh motivation and strong customer focusQuick… 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
