- Novo Nordisk Inc. (Boulder, CO)
- …and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert ( SME ).This position is also responsible ... and/or stakeholder requirements Acts in role as primary process SME for the Change Control process at NN Boulder...of submitted change requests in the NN system Provides SME support to direct reports and other employees working… 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
- 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 ... 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)
- …molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a subject matter expert for this lab, and also for the ... other critical activity workstreams to enable lab startup. They will also become a subject matter expert for a Grade C lab in the facility.-The selected… more
- Merck & Co. (Durham, NC)
- …needed 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 ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… 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)
- …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
- Merck & Co. (Boston, MA)
- …candidate will lead PDMB efforts as a project-team representative and PK/PD subject matter expert , regularly interacting with multi-disciplinary discovery ... this exciting position, your primary roles will include:Project-team representative and subject matter expert on protein therapeutic-based PDMB… more
- Merck & Co. (Rahway, NJ)
- …limited to:Utilizes specialist knowledge and experience in dermatology to serve as the company's subject matter expert ( SME ) in companion animal ... our company's Animal Health as a scientific speaker and veterinary professional expert at regional and national meetings by communicating key scientific and… 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
- Merck & Co. (Rahway, NJ)
- …advice, counseling to site leadership, and on-site supervision. The AD may serve as a subject matter expert for EQA and Division in specific Quality systems, ... In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months… 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
- 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
- Eisai, Inc (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
- Merck & Co. (North Wales, PA)
- …including assignment of resources, professional-development, and performance management.May serve as a subject matter expert and/or participate on process ... accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12)… more
- Merck & Co. (Durham, NC)
- …ability to train others. Works independently, Trains others, and ability to trouble shoot, Subject Matter Expert in automated systems (SAP, MES, DeltaV). ... In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Maintains current knowledge of industry best practice in AI/ML methodology- May act as Subject Matter Expert for AI/ML by providing guidance and support ... to Data and Statistical Science team members as well as represent the department in cross-functional teams- Responsible for monitoring and applying regulatory guidance and industry best practices- Demonstrates leadership within AI/ML by partnering with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to ensure credibility and competency of the ... conditions and areas of opportunity aligned with Therapeutic Area priorities Utilizes subject matter expertise and analytical tools to provide deeper customer… more
