- BioAgilytix (Boston, MA)
- …to GxP guidelines)Essential Responsibilities: Data Review & DocumentationPerform Quality Control (QC) technical and scientific and compliance review of data and ... quality management systemsResponsible for troubleshooting and overseeing resolution of technical issues that arise from the use of the LIMSPlans future workflow… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/GCP and other regulatory requirements. Collaborate with ... Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Novo Nordisk Inc. (Irvine, CA)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership ... projects for NACD and Novo Nordisk (eg, clinical trial site staff , clinical research vendors). Manages relationships with multiple internal stakeholders relevant… more
- Eisai, Inc (Nutley, NJ)
- …organization's overall security objectives and industry best practices.2. Leadership and management : Lead a team of infrastructure technical security ... will dotted line report into the Global Security & Compliance team (second line of defense). The primary objective...professional development goals can be achieved.3. Identity and Access Management (IAM): Oversee staff in the development,… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation ... Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of… more
- Merck & Co. (Rahway, NJ)
- …individual to work in a fast-paced job that provides a high degree of technical , project, and people management responsibility. - This SSO Facility Lead role ... to lead and support facility operations, process development activities, compliance investigations/change management , authoring of GMP documentation, and… more
- Merck & Co. (Rahway, NJ)
- …site relationships through all-phases of the trial.Performs clinical study site management /monitoring activities in compliance with ICH-GCP,-Sponsor SOPs, Local ... Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a-country.-Under the oversight of the CRA manager the… more
- Merck & Co. (Durham, NC)
- …finances, labor, employee, environment and safetyTactical and strategic Shift(s) management , including collaboration with indirect staff ;Promote the behaviors ... evaluation.- Provide feedback and input on performance evaluations for indirect staff .- Support Talent Management .Direct, coordinate, provide guidance and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position To ensure compliance with all Federal regulations and company SOPs regarding safety reporting from both ... US marketed products (drugs and devices). To support workflow management and coordination of all daily operations of Product...and devices). To contribute and support activities related to compliance reporting and quality tasks in order to ensure… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …ability to effectively collaborate with a broad variety of executives, scientific leaders, technical staff , administrative support staff , and all other ... & Mentorship: Manage and mentor a team of Principal Investigators and associated technical support staff . Foster an environment of innovation, collaboration and… more
- Catalent (St. Petersburg, FL)
- …Manager may oversee a staff from five to ten including Sr QA Technical Reviewers and QA Product Managers. Responsible for ensuring the site is following cGMP ... Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The Department has… more
- Merck & Co. (Rahway, NJ)
- …to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Specialist -Engineering position will report ... the Company's pipeline. This role may support facility operations, support compliance investigations/change management , author GMP documentation and manage/lead… more
- Eisai, Inc (Nutley, NJ)
- …in implementing and maintaining robust cybersecurity practices, including risk management , access controls, network security, and compliance , is ... Security, and provide leadership to managed services vendors. Organizational management responsibilities include resource prioritization, alignment with the CIO… more
- BioAgilytix (Durham, NC)
- …right at home here at BioAgilytix.Essential ResponsibilitiesPerform Quality Control (QC) technical , scientific, and compliance review of data and documentation ... of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will...QC review observations and work closely with the scientific staff to ensure data integrityCollect metrics data used to… more
- Novo Nordisk Inc. (Boulder, CO)
- About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as ... and process development, the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance . Takes ownership to deliver upon near-term North America Clinical ... projects for NACD and Novo Nordisk (eg, clinical trial site staff , IRBs, clinical research vendors). Manages relationships with multiple internal stakeholders… more
- Merck & Co. (Durham, NC)
- …personal integrity, credibility, and energy Strong planning, scheduling, and time management skills- Experience in Operations, Quality, Technical Operations, ... comprehensive technology transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or academic clinical research background Working knowledge of biostatistics, data management , clinical operations and scientific and technical processes ... Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams. Will be interfacing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or academic clinical research background Working knowledge of biostatistics, data management , clinical operations and scientific and technical processes ... Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management , CMC and Regulatory Affairs teams. Will be interfacing… more
- Merck & Co. (Baton Rouge, LA)
- …breakdown, duration of the work, resources required, etc.).Organizes work in compliance with safety rules.Drafts work orders.Enters information in the MP2 ... (computerized maintenance management system).Makes production reference changes on sensitive equipment.Follows applicable methods and procedures.Advises on and… more
