- Legend Biotech USA, Inc. (Raritan, NJ)
- …leading to sustained right first-time execution. Serve as subject matter expert for Compliance & Training systems . Knowledge of LMS system. Supports the ... training curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processing. Prepares and maintains training lab,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for procedure alignment based on roles. Serve as subject matter expert for Compliance & Training systems . Make recommendation for future system upgrades. ... within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems . Knowledge of cGMP… more
- Aequor (Seattle, WA)
- …data needs/gaps to ensure a smooth cross-site material transfer process. Serve as a subject matter expert (SME) for cross-site material transfer operational ... situations with competing project priorities. BA or BS degree; preferably in IT Systems or related field, and/or equivalent experience desired 8-10 years of business… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol defined analysis endpoints (primary, secondary, etc.) thereby serving as a subject matter expert for all external data management business ... collection and processing requirements are met. Serve as the subject matter expert to data...required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools is a plus… more
- Merck & Co. (Rahway, NJ)
- …coordination, and alignment of information architecture efforts with business objectives.Act as a subject matter expert and provide training and guidance on ... enable efficient and seamless access to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy,… more
- Merck & Co. (Rahway, NJ)
- …ongoing demand based on priorities and assesses the impact of system updates. Serves as subject matter expert to consult with end-users on appropriate system ... (COE's). The Senior Specialist will support learning and HR systems as well as assess and manage new demand...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Durham, NC)
- …recurrence including the development and implementation of corrective actions.Over time, become a subject matter expert (SME) in specific process steps, ... automation technology platforms, and specific systems .Over time, becomes expert practitioner of structured...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to support MCT activities. The Director serves as primary functional partner and MCT subject matter expert for the MCT integrated technology ecosystem and ... with the Digital Strategy Innovation team- Act as a subject matter expert in MCT...and procedures- Define key reports and insights from MCT systems ; track and communicate key metrics- Proactively identify potential… more
- Aequor (Seattle, WA)
- …LMS File and maintain training records for easy retrieval. Partner with the inspection/audit subject matter expert to generate LMS reports and/or retrieve ... record control of training information with input from users, subject matter experts, trainers and other learning...Bachelor's degree preferred 3 or more years of relevant systems experience in a regulated industry required, preferably in… more
- Merck & Co. (Rahway, NJ)
- …to automation/OT or IT systems .Participate in audits and training programs as the subject matter expert (SME) for area of responsibility. Data: Utilize ... play a crucial role in supporting the process automation systems within clinical manufacturing.-The Automation Specialist - Engineering Auto...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …instrumentation & control loops.Working knowledge of general OPC interfacesSubject Matter Expert on Control SystemsUnderstanding of Object-Oriented ... projects, and the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist -… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …data standards and data cleaning needs for DS Programs / Studies.Serve as the subject matter expert for Study Data Managers during the planning/start-up, ... or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a plus. Daiichi Sankyo, Inc. is… more
- Merck & Co. (Durham, NC)
- …to ensure the right support/awareness is given to issues as they ariseServe as an Subject Matter Expert (SME) during tours to provide area/process overview ... they must become proficient in the use of manufacturing systems and knowledgeable of site procedures in order to...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …to COM team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for ... at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems . Financial forecasting in conjunction with Sr.COM /other roles.Executes and oversees… more
- Merck & Co. (North Wales, PA)
- …as described in worldwide regulations and industry standards, and trend reporting. Maintain a subject matter expert level of knowledge related to these ... of required Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination to ensure timely and compliant implementation of process improvements. Serves as Subject Matter Expert (SME) in preparation for and during ... regulations and FDA/EU guidance. Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP. Excellent written and… more
- Eisai, Inc (Nutley, NJ)
- …team ensuring timely and accurate review and processing of claims.Serve as a subject matter expert supporting internal and external business partners ... impact analysis.Serve as business lead to continually improve and maintain efficiency of systems and processes to ensure accuracy and completeness of data flow for… more
- Eisai, Inc (Nutley, NJ)
- …development of action plans. Build training documents to ensure optimal use of tools.As " Subject Matter Expert " this position interprets key business reports ... Sales through regular feedback meetings and surveys to continually improve systems and processes aimed at increasing Field effectiveness and company… more
- Tris Pharma (Monmouth Junction, NJ)
- …evaluate and communicate safety observations. The incumbent functions independently as a subject - matter expert (SME) while working collaboratively with key ... plans, informed consent forms, Clinical Study Reports (CSRs), etc.); Provides expert safety guidance to clinical trial project teams and/or external partners… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide ... Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties may be assigned,… more
