- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health Authorities. ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...industry best practice in statistical methodology. May act as Subject Matter Expert for Statistics, by providing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in accordance with business requirements and provide technical and data subject matter expertise where required.Responsibilities- Develop and maintain our ... projects and development of data management technologies. Provide technical expertise and subject matter expertise. Provide risk analysis, business and technical… 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 needs. ... ensure DSI data collection and processing requirements are met. Serve as the subject matter expert to data management staff during the planning/start-up, conduct… more
- Merck & Co. (Rahway, NJ)
- …global level. Demonstrate leadership in developing and connecting a global network of subject matter experts to share intelligence and to support strategic ... of relevant healthcare environment matters including policy, regulatory, health technology to identify key issues relevant to strategic planning initiatives… more
- Merck & Co. (Rahway, NJ)
- …company's Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, standalone, ... system validation process, thereby promoting permanent inspection readiness.Develop and maintain a subject matter expert level of understanding for the company's… more
- Merck & Co. (Durham, NC)
- …ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert during tours to provide area/process overview information ... inclusive team culture including significant interaction with Operations, Quality, Automation, Technology , and other groups as required. Primary activities for this… more
- Merck & Co. (Rahway, NJ)
- …regulatory, and health technology .Developing a global internal network of subject matter experts to share intelligence and support strategic ... design and execution of competitive planning initiatives for products subject to significant competitive events.Ensuring the effective implementation and integrity… more
- Merck & Co. (Rahway, NJ)
- …recognized in the pharmaceutical industry, through publications/presentations, for subject matter expertise.-Primary Location: NA-US-NJ-Rahway;-Travel: Limited, ... R&D and our Manufacturing Division colleagues to complete process characterization, technology transfer to commercial manufacturing sites and authoring of regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Strategic Imperatives (SIs) and process improvement workstreams, partnering with cross-functional subject matter experts.-Support the build of industry expertise ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...Transcelerate, WCG/Avoca, SCOPE, SCRS, DIA, etc.-Work with and/or support subject matter experts to determine needs and… more
- Merck & Co. (Durham, NC)
- …inspections and audits and other validation activities by serving as the subject matter expertUnderstands and supports all GMPs, safety, and environmental ... the efficient operation of variety of automated processing and information technology systems.- Leads in installing and...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Merck & Co. (Rahway, NJ)
- …prefilled syringes, auto-injectors, on-body infusers/injectors, inhalers, and more. As a subject matter expert in medical device and combination product ... candidate will play a pivotal role in driving seamless technology transfers and conducting investigations as needed for our...Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Develop positive relationship with the QA team, Quality Control, Information Technology , Maintenance, Manufacturing personnel, Technical Operations personnel, ... Company Information Legend Biotech is a global biotechnology company...teams. Review/approve documents as a Quality on the Floor Subject Matter Expert (SME). Remain current in… more
- Taiho Oncology (TX)
- …on approved medical platforms/strategies and MSL initiatives Serve as technical/scientific subject matter resource to Taiho commercial personnel, if requested ... the field of cancer treatment evolves, we evolve with it. Advanced technology , dedicated investigators, and incomparable facilities: these vast resources empower us… more
- Aequor (Newbury Park, CA)
- …initiatives. Work with stakeholders to gather requirements and develop solutions. Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory ... based on rules/compliance. Education background preferred for this role: Science/ Technology -based degrees are preferred OR industry-specific experience. If the… more
- Merck & Co. (Rahway, NJ)
- …of manufacturing GMP steps, demonstration of new manufacturing technology /processes, training opportunities for improved manufacturing process development and ... instrumentation & control loops.Working knowledge of general OPC interfacesSubject Matter Expert on Control SystemsUnderstanding of Object-Oriented languagesStrong background… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sites/ Institutional Review Boards (IRBs), and other site personnel as needed- Study-specific subject matter expert (ME) for internal audit or Health Authority ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… 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 front line ... Company Information Legend Biotech is a global biotechnology company...developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor… 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, conduct ... reports and / orExternal Data listings.Remains current with and disseminates information about external data trends and advancements, regulatory requirements, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and communicate safety observations. The incumbent functions independently as a subject - matter expert (SME) while working collaboratively with key internal ... spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but our team… more
- Eisai, Inc (Nutley, NJ)
- …cost-utility, and budget impact analyses of health technologies.Serve as the subject matter expert and independent project lead responsible for ... economics and development of models suitable for submission to Health Technology Assessment agencies or to support other reimbursement decisions.Knowledge of… more
