- Novo Nordisk Inc. (WA)
- …safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for all monitoring and site management activities. Takes ... executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring , and Closure) for assigned sites and clinical trials Verifies safety… more
- Eisai, Inc (Nutley, NJ)
- …global IT compliance risk framework.Control Gaps: Identify and manage IT compliance control gaps. Monitoring Programs: Develop programs to manage IT ... participate and drive internal and external audits.Awareness Training: Promote IT compliance awareness training programs.Performance Monitoring : Define KPIs and… more
- Eisai, Inc (Los Angeles, CA)
- …through of representatives selling efforts in accordance with strategic plans and compliance , monitoring and driving sales goals, and coaching Sales ... Managed Markets, Trade Relations, Value Access, Contracting, Medical, HEOR, Marketing, Compliance ) to develop compliant means to understand account needs and educate… more
- Merck & Co. (KS)
- …growing long-term relationships and sales opportunities for Livestock Intelligence Monitoring products and services across the entire business enterprise.-These ... utilizing all available resourcesManage new and existing Livestock Intelligence Monitoring product portfolio and provide on-site sales support and coordinate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role ... OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for regulatory ...required, run reports and conduct data analysis to support monitoring of key performance indicators; support the preparation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversee performance of CROs, third party vendors, and contractors, including co- monitoring , to ensure compliance with study protocol, and identifying areas ... internally and externally Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. We are currently seeking a Compliance Intern for the year (June 2025 - May 2026). This part time position ... works for approximately 20 hours per week. Responsibilities: The Compliance Intern will provide support to the Policy, Training and Communications team and the … more
- Eisai, Inc (Raleigh, NC)
- …global talent development. Participates in and promotes hhc and compliance activities.Lead process performance monitoring , operational excellence activities, ... and process improvement strategies.Works with the Biologics US staff to provide recommendations of potential technology based strategic initiatives that could lead to technology improvements that would maximize patient benefit, improve product quality and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile ... Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to… more
- Merck & Co. (Durham, NC)
- …documents) to support project and future operations.Identifies and addresses compliance , environmental, safety, and process deviations as appropriate while ... execution.Maintains detailed knowledge of equipment and processes.Identifies and addresses compliance , environmental, safety, and process deviations as appropriate while… more
- Aequor (Bothell, WA)
- …assessment of manufacturing records, test method data, deviations for GMP compliance to enable lot release, specifically: a. Review executed batch production ... records and test data to ensure compliance with approved procedures and GMP expectations b. Review...reports to Management, annual product quality reviews and process monitoring 5. Assign part and lot numbers and maintain… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDUTIES:Design and configure global trade compliance processes in SAP Global Trade Services (GTS) & SAP Order to Cash (OtC) modules.Develop and ... implement end-to-end trade compliance solutions, including import/export compliance , customs management, risk management, and trade document management.Design… more
- Merck & Co. (Rahway, NJ)
- …the entire cycle of clinical development, including study design, placement, monitoring , analysis, regulatory reporting, and publication. - Specifically, the Senior ... trials (design, operational plans, settings) based on these clinical development strategies Monitoring and managing the conduct of ongoing or new clinical trials for… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …team of manufacturing professionals and performing aseptic interventions, environmental monitoring , and other microbiology and operational tasks. This newly created ... higher level managerial roles in the industry.Job Responsibilities: Maintain compliance with company policies, cGMP, safety standards, and regulatory requirements.… more
- Aequor (Golden Valley, MN)
- …guidance in project meetings and support the regulatory department in our compliance activities. Regulatory is a strategic partner that helps the business to ... fee reports and submit to the states Review labels for AAFCO and FDA compliance and track changes Commercial feed sample test report distribution to R&D Submit… more
- Aequor (Thousand Oaks, CA)
- …including analysis and reporting of trends in quality measures Ensure vendor compliance with approved processes and training requirements Audit & external inspection ... monthly measurement of Quality Control and Retrospective QA metrics Oversee performance monitoring and relay quality metrics to vendors Analysis of QC trends… more
- Eisai, Inc (Nutley, NJ)
- …preparation and follow-up ( eg Informed Consent Form, eTMF fling plan, Co- Monitoring Plan) Creates Clinical Trial Agreement requests using the legal tracker and ... Epic site Coordinates reviews for essential materials such as ICFs and Co- monitoring plans CRO and Vendor Contributions: Assist in managing ancillary supplies with… more
- Merck & Co. (North Wales, PA)
- …sets of data, experience looking for trends in data, segmentation analysis, monitoring campaign progress and identifying intervention points and business solutions - ... engines, etc.). Experience with Agile Team methodology. Understanding of compliance -related concepts that govern pharmaceutical marketing and sales activities.… more
- Merck & Co. (Rahway, NJ)
- …and accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a culture of diversity, inclusion, and equity. ... microbioreactor systems, and advanced in situ analytics for process monitoring and control.Experience with state-of-the-art cell culture processes including… more
