- Eisai, Inc (Nutley, NJ)
- …requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT compliance initiatives (strategic and ... years' experience in an Information Security, IT Governance or Risk and Compliance -based role.Experience managing global initiatives and matrixed resources,… more
- Merck & Co. (Rahway, NJ)
- …Intellectual property (IP) document management system; enhance IP's tools and technology portfolio and information governance programs; and design and ... audit and data integrity reports to identify, investigate and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary This position will be part of the Global Compliance & Risk Management organization and will report directly to the Head ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 120 years of scientific expertise and a presence in… more
- Merck & Co. (Upper Gwynedd, PA)
- …and Compliance Council regarding the Quality Management System (QMS), Risk Assessment Categorization Tool (RACT), Quality Plans and Regulatory Health Authority ... `quality by design` within clinical development programs, using a risk -based approach. The incumbent will be responsible for the...to new and emerging risks through the use of technology . In particular this will include developing and maintaining… more
- Merck & Co. (Rahway, NJ)
- …space, including process flow diagrams and engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOur Company Information Technology organization partners with colleagues across the business to help serve our patients and customers around the ... our company's contribution to global medical innovation by leveraging information and technology .-One of the key priorities...but not limited to Data Marketplace, Data Quality, Data Risk Management c) Value Realization with use of these… more
- Merck & Co. (Durham, NC)
- …members of the team. - Requirements: Must possess a Bachelor's degree in Science, Information Technology , Engineering and at least 5 years of experience in ... facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be… more
- Merck & Co. (Rahway, NJ)
- …around the use of new cloud features to establish an acceptable risk posture. Define the requirements, best practices, and lead the collaborative development ... development, engineering, and deployment of security controls used to protect. Ensure compliance with all requirements applied to cloud services and technology .… more
- Merck & Co. (Rahway, NJ)
- …environment between cross-functional teams including device development, device technology , procurement, supply chain and manufacturing.Establish clear performance ... requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and development to… more
- Merck & Co. (Rahway, NJ)
- …process modeling, and data analysisExperience with chemical engineering-related technology developmentExperience with risk assessments, process characterization, ... experiments aimed at achieving research goals related to process development, technology development, and production of active pharmaceutical ingredients (API).- The… more
- Merck & Co. (Rahway, NJ)
- …adequacy of internal controls. This includes performing walkthroughs and testing information technology general controls (ITGCs) to provide reasonable assurance ... confidence in a changing world.-We provide value-added independent and risk -based audit, assurance and advisory services.Position Responsibilities:The successful incumbents… more
- Merck & Co. (North Wales, PA)
- …application related decisions that may or may not have a global impact.-Ensure compliance to Company, local laws and agency regulations and related guidance around ... technology .-Apply data stewardship and data governance principles in the...developing and communicating high-level UAT plans.-Responsible for completion of risk and privacy assessments and ensure adherence to … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... and continued process verification (CPV)Recognize and act on potential compliance issues and opportunities for process changes/improvement.Provide technical expertise… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams Responsibilities Provide the interface between the business and the technology providers to deliver R&D information applications solutions. Establish ... unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …instructions.Develop positive relationship with the QA team, Quality Control, Information Technology , Maintenance, Manufacturing personnel, Technical Operations ... we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management activities. Takes ownership to ... changing environment, supporting a future-focused approach, leveraging competencies, tools and technology . Relationships Reports to a Manager (or above) within NACD.… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology .Our science and technology make us unique, but it is ... contracts across the organization. The incumbent reviews contracts to ensure compliance to company policy, government specifications and other legal and company… more
- BioAgilytix (Durham, NC)
- …using Smartsheet and other reporting tools.Minimum Qualifications: EducationBachelor's degree in Information Technology , Computer Science, Life Sciences, or a ... comprehensive implementation, customization, and optimization of the LabVantage Laboratory Information Management System (LIMS). This onsite role requires close… more
- Merck & Co. (Durham, NC)
- …(ie Maintenance, Global Engineering, Quality, and Operations} to ensure a successful technology transfer, filing, and licensure for a new HPV vaccine drug substance ... documents to support regulatory filings including technical reports and risk assessmentsSupport aspects of regulatory inspections by presenting and defending… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist, Quality Systems and Compliance (P3) Our company is expanding its global recombinant vaccine production network by investing and ... for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.- Responsible for… more
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