- Merck & Co. (Durham, NC)
- …also be responsible for working directly with Logistics and Operations managers and personnel as a subject matter expert ( SME ) in support of training and ... and SME Support Working directly with Logistics managers and personnel as a subject matter expert ( SME ) in support of training and implementation of… more
- Novo Nordisk Inc. (WA)
- …intellectual property. Manages relationships with select government agencies. Serves as a subject matter expert . Solicits internal stakeholder insights to ... to NNI. Essential Functions Achieve deep understanding of, and serve as a subject matter expert on, assigned policy areas and the potential impact to… more
- Merck & Co. (Rahway, NJ)
- …CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert . Proactively identify, execute and manage ... clinical supply QMS through participation as topic team member and/or subject matter expert . Represent Development Quality on inter-departmental and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations team based in Raritan, NJ. Role OverviewThis individual will serve as a subject matter expert for warehouse operations and perform daily warehouse ... comply with cGMP regulations and safety guidelines.Key Responsibilities Serve as a subject matter expert for warehouse operations and perform daily warehouse… more
- Eisai, Inc (Nutley, NJ)
- …policies. Participate in review of CME grants. Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) ... experience in the pharma/biotech industry. OR a combination of equivalent education, deep subject matter expertise in relevant area along with a broad overall… more
- Eisai, Inc (NJ)
- …evidence generation programs for assigned products. Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances ... and real-world evidence generation. The Medical Director will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic… more
- Merck & Co. (Millsboro, DE)
- …with the USDA, internal MAH departments or international permittees, where applicable.May serve as subject matter expert in regulatory matter (s), such as ... but not limited to labeling, facility documents, relative Potency assays, antigen overages, licensure processes, permits, ingredients of animal origin and ensure that these meet the requirements of the USDA and export markets.Develops and maintains profound… more
- Novo Nordisk Inc. (Durham, NC)
- …Novo Nordisk and help us make what matters. The Position Serve as a Lead & Subject Matter Expert ( SME ) to provide technical expertise supporting site ... MES, SAP, PI Historian) Serve as a Lead and SME in supporting audits & inspections for specified AMS...improvement, & project management Serve as the Lead and SME to operate within compliance with a quality mindset… more
- Eisai, Inc (Raleigh, NC)
- …and evaluating the impact of deviations or events on product quality. \tActing as a Subject Matter Expert ( SME ) during regulatory inspections in assigned ... area(s) of responsibility.This role requires a high level of independence, attention to detail, and strong communication skills to foster effective collaboration across teams.ResponsibilitiesExecute core processes within Quality area: Review manufacturing… more
- Aequor (Houston, TX)
- …improvement initiatives based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert ( SME ), Level I, for the ... Warehouse / Supply Chain team Responsible for all Level I key accountabilities: o Responsible for the initiation, investigation and completion of Minor process deviations o Demonstrates technical writing for the educated but uninformed reader, translate simple… more
- Merck & Co. (Rahway, NJ)
- …and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert . Account and manage for the demands per region ... partner with the business via managing specific Order to cash process area or subject eg Order management, Customer Master. Based on our SAP template and the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... Qualification Protocols) with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site… more
- Merck & Co. (Rahway, NJ)
- …managed development of DHF (design history file) deliverables for medical devicesRecognized as a subject matter expert in at least one medical device ... development or design controls areaKnowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC,… more
- Eisai, Inc (Nutley, NJ)
- …generation plans needed to optimize AD diagnostic journey.Serve as a medical leader and subject matter expert on AD diagnosis and proactively stay up ... to date for external education as well as internal trainingLiaise with external stakeholders to solicit feedback and strengthen Eisai's medical reputation and presence in the AD community.Qualifications: Advanced scientific degree (MD, PhD, PharmD) with 4+… more
- Merck & Co. (Rahway, NJ)
- …equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert , assist with acceptance testing (FAT, SAT), ... installation/qualification of equipment at our manufacturing sites, interrogation of subassembly processes at our device supplier sites, and provide hands-on troubleshooting to operations as needed. Key Responsibilities: Experience with, and a fundamental… more
- Aequor (Devers, TX)
- …for Procurement Activities: Serve as the Sourcing Process Data Lead and transactional Subject Matter Expert and drive best-in-class business processes and ... acumen for successful ERP implementation. Consulting and Escalation Support: Act as the SAP Procurement and ASL Champion, providing consulting and escalation support. Leadership and Guidance: Provide leadership and guidance to the Project Team and… more
- Aequor (Athens, GA)
- …specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic document management systems and ... migration of records from legacy systems. Electronic Document Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration. Provide routine user support. Electronic… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective compliant training performance leading to sustained right first-time executionServe as subject matter expert for Compliance & Training ... systemsKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsJob duties performed routinely require exposure to and handling of biological materials and hazardous chemicalsJob duties include operating an industrial vehicle;… more
- Repligen (Rancho Dominguez, CA)
- …and the ability to drive projects with minimal oversight.Responsibilities Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing ... systems. Lead projects in equipment design, tech transfer, process validation, and facility upgrades. Conceives, plans, and executes projects or aspects of projects related to the strategic needs of the company. Partner with global engineering teams to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …issues/troubleshooting. Supports CAPA investigations / implementation.ICSR Standards Oversight: Acts as subject matter expert in ICSR standards, decision ... making and trouble shooting. Identifies CRO/vendor training as needed. Reviews overall processes and identifies areas of concern, arranges for remediation. Performs review of data entry convention documents, PVA reviews and SAE flow plan / data management plan… more
