- Formation Bio (New York, NY)
- …a culture of quality excellence, accountability, and continuous learning. Serve as a subject matter expert on quality assurance matters during regulatory ... compliance with requirements. About You Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the… more
- Formation Bio (New York, NY)
- …GMP QA strategy and execution for Formation Bio's portfolio. Acting as the QA subject matter expert , this role supports CMC development activities, including ... excellence, accountability, and continuous learning. Serve as the QA subject matter expert for all...corrective and preventive actions (CAPA effectively. Proficiency in quality management tools and methodologies (eg, risk assessment,… more
- Merck & Co. (Rahway, NJ)
- …across our Company's commercial digital marketing division for Global stakeholdersAs subject - matter expert in commercial analytics data domains, ... country program rollout with cross divisional and market stakeholdersStrategic thinking, risk management , and roadmap planning for data product evolutionEnsure… more
- Merck & Co. (Durham, NC)
- …to ensure the right support/awareness is given to issues as they arise Serve as an Subject Matter Expert ( SME ) during tours to provide area/process ... employee development, routine 1:1 meetings and coaching, recognition, and performance management ). Additionally, they must become proficient in the use of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …directly from sites/ Institutional Review Boards (IRBs), and other site personnel as neededStudy-specific subject matter expert ( SME ) for internal audit ... medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1-3… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Biostatistics and Data Management Data Operations team and serves both as a subject matter expert and leader of a group responsible for the business ... group. This position reports to the Associate Director Data Management Operations. Business administration activities within the CDR system...the Clinical Data Repository. Functional Expertise: Serve as a subject matter expert and provide… more
- Merck & Co. (Rahway, NJ)
- …of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise Mentors ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …resources and knowledge related to promotional materials. Serve as a scientific resource, subject matter expert and mentor to the Medical Promotional ... new ideas, solutions, methods or opportunities; foster innovation through appropriate risk -taking and experimentation to ensure that the Medical Promotional Review… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …liaison for the quality team in support of site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group ... reports, interpret results, and generate technical conclusions consistent with quality risk management principles.Recognize patterns and trends in reported data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and functional team members.Maintains global integrated project plans, project timelines, risk management plans and communication plans. Resolves complex ... immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic… more
