- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the submission dossier, where applicable, and to ensure timelines and business objectives are met. Subject matter expert ( SME ) in 2 or more focus ... and due diligence activities for assigned product(s), as neededActs as audit/inspection Subject Matter Expert ( SME ) for safety surveillance and risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical research diversity and inclusion - Health Authority Interactions- Point of contact / subject matter expert ( SME ) for inspectors and/or auditors ... with regards to diversity and inclusion in our clinical studies- Contributes to HA response / leads CAPA activities related to diversity and inclusion Qualifications: Successful candidates will be able to meet the qualifications below with or without a… more
- Lundbeck (Bothell, WA)
- …review SOPs, development reports, and technical reports In partnership with QC, serve as the Subject Matter Expert ( SME ) in the transfer of analytical ... needed) with method transfers, qualifications and validations and ultimately serving in a Subject Matter Expert role. Key to the position is a thorough… more
- Tris Pharma (Monmouth Junction, NJ)
- …Officer (CDO), President and other member of Senior Leadership, she/he serves as a Subject Matter Expert ( SME ) regarding Pain specific clinical ... Hyperactivity Disorder (ADHD), Overuse Disorders (OUD), etc.) ESSENTIAL FUNCTIONS Applies expert Pain knowledge and experience to provide strategic leadership and… more
- Merck & Co. (Rahway, NJ)
- …analysts on technology-related business problems, leveraging IT colleagues as appropriate. Acts as subject matter expert on Supply Chain solutions, primarily ... desirable Hands on with full Life Cycle Implementations with emphasis as Subject Matter Expert in SAP- Deep understanding of Integration through middleware… more
- Merck & Co. (Rahway, NJ)
- …on technology-related business problems, leveraging IT colleagues as appropriate. Acts as subject matter expert on CTSM solution, primarily responsible ... desirable. Hands on with full Life Cycle Implementations with emphasis as Subject Matter Expert in SAP.- Deep understanding of Integration through middleware… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …current disclosure requirements and participates in the strategic planning for future change. Subject matter expert on global clinical trial registration, ... of EMA Policy 0070 (and other external policies) and its subsequent compliance. Subject matter expert on global clinical trial registration, summary result… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meets quality requirements and best practices in medical coding. Serves as a subject matter expert for medical coding. Responsibilities Leadership, ... SOPs, and other relevant guidelines. Functional Expertise:Serves as a subject matter expert in medical codingReviews/approves clinical study related… more
- Tris Pharma (Monmouth Junction, NJ)
- …initiatives/projectsManages, coaches and mentors a small team of direct reports Serves as a Subject Matter Expert ( SME ) and provides medical/scientific ... expertise by working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and analyses clinical trial data and translates data into actionable plans at product levelContributes to Medical aspects of Regulatory issues related… more
- Eisai, Inc (Nutley, NJ)
- …input into the lifecycle management strategies in responsible therapeutic areas. Medical/Scientific subject matter expert : Serve as medical leader and ... subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review,… more
- Eisai, Inc (Nutley, NJ)
- …input into the lifecycle management strategies in responsible therapeutic areas. 30%Medical/Scientific subject matter expert : Serve as medical leader and ... subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and how it will affect or can be used in our current Models Act as a subject matter expert ( SME ) for Anaplan to the organization as well as championing ... best practices in Anaplan model building and lifecycle management Physical Requirements 0-10% overnight travel required. Qualifications Education Level: Minimum bachelor's degree in business, engineering, Information systems or other relevant subjects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …led clinical trials requiring Clinical Trial Material (CTM) and will also serve as the Subject Matter Expert ( SME ) for the SaaS and cloud-based ... internal stakeholders and vendors to address project challenges as needed.- Serve as SME for Prisym 360 label phrase library maintenance and scope expansion, as… more
- Eisai, Inc (Raleigh, NC)
- …(where applicable), industry standards and internal company policies.Applies knowledge and experience as a Subject Matter Expert ( SME ) across and beyond ... the boundaries of packaging equipment. Requirements Education: Bachelor of Science in a relevant engineering discipline (eg, Mechanical, Electrical, Industrial), or a related field (preferred) or BS degree with commensurate experience (required)Technical: 5+… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert in meeting or teleconferences with Health ... current knowledge of industry best practice in statistical methodology. May act as Subject Matter Expert for Statistics, by providing guidance and support to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary: Manager, Sales Training and Development - Oncology serves as the training subject matter expert with their assigned secondary customers (Brand ... & Marketing Teams). This role serves as training representative on the secondary customer's commercial brand teams and coordinates brand/customer training strategies and needs. In addition, this individual serves as the primary training staff and is… more
- BioAgilytix (Durham, NC)
- …from initiation through delivery.Trains users on the use of automated systems. Serve as subject matter expert ( SME ) for select laboratory systems ... and existing business needs. This position serves as an Automation Expert , ensuring the efficient operation of automated laboratory equipment, conducting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter expert ( SME ) to support ... enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs) and Food and Drug Administration (FDA) requirements Provides technical Subject Matter Expert ( SME ) Packaging Component ... support for internal departments (Research and Development (R&D), Supply Chain, Marketing, QA, Quality Control (QC), Regulatory, Packaging, project teams, etc.); Collaborates closely with internal cross functional teams and external vendors and manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on the Floor Subject Matter Expert ( SME ). Remain current in skills ... and industry trends. Requirements Minimum of a Bachelor's Degree in Science, Information Science or equivalent technicaldiscipline is required. Minimum of 6 years relevant work experience is required. It is preferable that the candidate hasexperience working… more
