- CHRISTUS Health (Bishop, TX)
- …groups, and departments. CORE COMPETENCIES Standard I: Utilizes the Nursing Process Uses critical thinking skills to assess the basic physical, psychosocial, ... practices and activities Standard V. Leadership Serves as a subject matter expert for patient care Gives continuing feedback, recognizes achievement, and recommends… more
- Merck & Co. (Rahway, NJ)
- …The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development, ... chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise. Mentors new team members and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring efficient operations for case processing and assessment. Serves as expert regarding case processing issues and provides support and escalation channels ... patients and healthcare professionals, with inquiries, case handling issues, and process improvements related to patient safety. Relationship Reports to the Head… more
- Shimadzu Scientific Instruments (Dallas, TX)
- …is seeking an QX Service Specialist to join our team! As the regional expert in our LCMS QX multiplexing systems , you'll provide critical field-based service ... suppliers of analytical instrumentation, physical testing, and environmental monitoring systems in the world. Ground-breaking scientific research, manufacturing ideas… more
- Insmed Incorporated (NJ)
- …Regulatory Submissions, and responses to regulatory authorities. As a content expert , this individual has a significant understanding of regulatory requirements and ... ICH guidelines (including E3 and E6), and knowledge of document management systems ; is capable of working independently with minimal supervision.What You'll Do:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …technical complaints, contact centers and related reimbursement support programs/services Expert in identifying and reporting adverse events, product technical ... scripts, including stewarding material through the Promotional Review Board process (if applicable) Optimizes multi-media communication (letters, emails, fax, text)… more
- Aequor (San Diego, CA)
- …implementing and reviewing computer system validation (CSV) protocols of GxP computerized systems .Serve as the CSV subject matter expert and provide guidance ... interpretation of global GxP guidance and regulations of computerized systems , electronic records, electronic signatures, and data integrity requirements.Collaborate… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director, will report to the Animal Health Global Quality Compliance and Technical Lead.-- ... (QMS) documents pertaining to USDA requirements for facility design, auditing, quality systems and ensure team and company adherence to these documents.Develop a… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert ... global and site-specific projects related to combination products and drug delivery systems .Ensure that all activities are conducted with the highest regard for… more
- Merck & Co. (Rahway, NJ)
- …critical non-pipeline activities in support of clinical supply planning group (eg, process improvement initiatives, subject matter expert roles, cross functional ... The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …standards, and industry best practices Proven experience in auditing, process improvement, and implementing documentation management systems Excellent ... The Position We are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE the Director, Logistics and Distribution Technology will...Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and regulatory requirements. This roles also serves as the subject matter expert in providing guidance, oversight and project management of assigned projects in ... and analysis results related to post-marketed products into patient safety systems ensuring completeness and accuracy Review auto-generated narrative for non-serious… more
- Insmed Incorporated (NJ)
- …expertise in adult learning methodologies and training development required.Subject matter expert in training field and ability to develop deep understanding in ... areas and products required.Forward looking, global mindset, with continuous process improvement mentality.Strong strategic thinking with ability to connect multiple… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a culture of accountability, collaboration, and continuous improvement Provide expert guidance to cross-functional teams regarding safety case management activities ... Process Development & Optimization Oversees medical review of individual...regulations and guideline Expertise in safety databases and quality systems Knowledge of NNI supported disease states preferred (eg,… more
- Repligen (Clifton Park, NY)
- …delivery, and productivity goals.Serve as the on-shift subject matter expert for molding and packaging operations, supporting technical problem-solving, tooling ... issues, and process challenges.Ensure proper setup, operation, and maintenance of molding...preferred.Proficient in Microsoft Office (Excel, Word, Outlook) and ERP systems such as SAP.Leadership Competencies:Demonstrated ability to lead and… more
- Merck & Co. (Rahway, NJ)
- …and Distribution Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug ... testing and qualification and leading execution of qualification of complex systems .-The candidate is expected to build inclusive, collaborative partnerships with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to management, as needed.Lead continuous improvement around development of new signal workflow/ process , development of quality systems and tools, updates to ... of change control, training material update, and end user support or process enhancement. In collaboration with the signal management head, this individual will… more
- Merck & Co. (North Wales, PA)
- …access for our ophthalmology portfolio. -The Director will be a subject matter expert on US health care ecosystem, interconnectivity of private and public payors, ... hospital delivery systems , as well as policy trends within the context...work and build partnerships Required Skills: Brand Strategy, Buy-and-Bill Process , Contracting Strategies, Digital Marketing, Market Access, Marketing, Marketing… more
- Insmed Incorporated (NJ)
- …initiatives, and manage EH&S staff.Build and maintain EH&S management systems , including documentation, standard operating procedures (SOPs), risk assessments, ... for EH&S matters with outside agencies.Acting as the primary EH&S regulatory expert for Insmed. Monitoring proposed EH&S regulations and legislation and solicits,… more
