- Insmed Incorporated (New York, NY)
- …experience.Other Pharmaceutical experience - Medical Information, Medical Strategy, Clinical management /trial experience and 2 years clinical or research experience ... competitive pipelines and lifecycle plans, medical and pharmacy benefits, quality programs, etc.)Committed to self-improvement.Travel RequirementsUp to 80% domestic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing ... The position will be heavily involved in close collaboration with the contractor quality and technical personnel and will partner with internal development teams on… more
- Merck & Co. (Rahway, NJ)
- …to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, accountable ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a detail-oriented Associate Director of Consolidation Accounting, tasked with the role of overseeing the accurate and timely ... enhancing their business acumen for future opportunities.Reporting directly to the Director of Consolidation Accounting, this role is integral to our financial… more
- Merck & Co. (Rahway, NJ)
- …our team. As the Technical Support Engineer, you will be working within the Quality Engineering Platform area as well as with cross functional areas (eg DevSecOps, ... benefits against what was predicted in the business case.Uses application management software and tools to investigate issues, collect performance statistics and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... requirements by their strong scientific background, excellent communications skills, and project management skills to derive high- quality reference data to meet… 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)
- …and actively contributing to Enterprise Architecture's vision of high- quality , light touch architecture governance. Responsibilities: Architecture:Delivering and ... stakeholders.Proactively identifying and solving the complex problems that impact the management and direction of our IT and business Strategy.- Develop strategies… more
- Merck & Co. (Rahway, NJ)
- …& connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs ... Clinical Supply Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Rahway, NJ)
- …of regulatory submissions. -Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and ... toCoordinate project planning, resourcing, progress reporting, troubleshooting and people management .Serve as the scientific/technical mentor for junior staff.- Provide… 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 ... study and post-marketing protocols and the Clinical Study Oversight Plan, day-to-day management of DS Safety Notification Letter (SNL) System and oversee TMF… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …grows. Relationships Reports to the Sr. Director , Patient Support Solution Quality /Safety Associate Director . Interacts with colleagues within Patient ... to maximize your potential with us? The Position The Associate Director will be the lead who...Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements Partners with compliance… 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
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managed elsewhere internally or at vendors. Relationships Reports to the Senior Director , Advanced Analytics & Innovation. Works closely across the entire NNI ... to derive insights Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP ... relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ManagementEstablish and enforce robust data governance… 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 ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
