- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , Automation Th is position will primarily be responsible for ensuring reliability and efficiency of site ... data collection systems and other strategies that optimize statistical efficiency and quality - Develop and maintain Site Facility Energy Regression models - Work… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research… more
- Merck & Co. (Rahway, NJ)
- …team at the FLEx Center in Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of ... to enable flexibility and speed of our company's pipeline.This person will: Lead and strategically plan on-the-floor batch manufacturing to ensure safety and… more
- Merck & Co. (Rahway, NJ)
- …and project management responsibility. The Specialist -Engineering position will report to the Associate Director , Engineering and will be a member of the EF ... compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of ... Quality team based in Raritan, NJ. Role OverviewThe Associate Director of Quality Project...in a sterile GMP environment. This role will oversee, lead and support quality activities for continuous… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary CMC Lead is responsible for supporting the overall CMC strategies within projects, and ... the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead ...with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cross-functional team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director , Program Management ... centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior..., Enterprise Program Management, this position requires a capable leader with strong technology and business acumen who is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management ... operational strategies for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and outcomes, addressing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned, ensuring onboarding of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training and Documentation management ... will take direction from global strategy and operational QA leader , however is also accountable to the VP of..., however is also accountable to the VP of quality . The incumbent is expected to understand and apply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on major… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU. ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics ... governance. Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs, cost, 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 ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… 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 ... policies and methodologies are understood and utilized. Serve as the lead "relationship manager" to proactively deliver strategic sourcing insights, optimal value… 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 ... capture the full discussion for archiving. Serve as the primary contact with FDA. Lead and prepare FDA submissions, including but not limited to briefing documents,… more
- Eisai, Inc (Nutley, NJ)
- …platform hardware/software, and networks). Essential Functions Strategy and Business Alignment 45% Lead the definition and design of high value solutions which align ... stakeholders including systems integration best practice and process excellence principles. Lead the definition of future state solution architecture by establishing… more
- DEPARTMENT OF TRANSPORTATION (New York, NY)
- …the Associate Deputy Commissioner of Cityscape & Franchises, the Executive Director will lead and oversee the planning, development, and implementation of ... Executive Director of Outdoor Dining DEPARTMENT OF TRANSPORTATION Full-Time...the transportation infrastructure crucial to the economic vitality and quality of life of City residents. DOT is an… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …procedural documents, and quality and inspection readiness for Clinical Operations. The Associate Director , will be a key member of the Connect Quality ... readiness activities. The position will partner closely with Research & Development Quality personnel. **Primary Responsibilities:** + Lead efforts to increase a… more
- Wolters Kluwer (New York, NY)
- …quality and reducing release timelines of our products. You will report to an Associate Director , Software Quality Assurance. **This role will be based in ... - 8 days a month in the office The ** Lead QE Architect** works as a technical leader...outcomes and align with business objectives. + Establish and co- lead the Quality governance process to identify,… more
- Wolters Kluwer (New York, NY)
- …to experience the value of connecting with colleagues. You will report to the Associate Director , Software Quality Assurance and work under the leadership ... **Software Quality Assurance Manager - Hybrid R0043698** **Summary:** The Wolters Kluwer Digital Experience Group co-creates products and solutions with Wolters… more
