- Eisai, Inc (Nutley, NJ)
- …with regulatory, organizational, and commercial requirements that govern the organization's technology systems and information assets.Purpose of role:Oversee IT ... Security Initiatives: Work with global and regional teams on information security and protection, as well as data...Systems Management required.Minimum of 10 years' experience in an Information Security, IT Governance or Risk and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise and a presence in ... hours per week. Responsibilities: This internship will support multiple projects in IT Risk & Security Governance. Partnering with team members, the intern will gain… 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...including but not limited to Data Marketplace, Data Quality, Data Risk Management… 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 ... IT risk management policies and practices Intellectual property (IP) Technology Management Design and implement a long-term technology roadmap that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including some international. Qualifications Education Level: Bachelor's degree in business, information systems, computer science, Data Science or related field ... managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Brochure, aggregate reports (DSUR/PLL), Prescribing information , Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)Collaborates with PSL(s) ... 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
- Merck & Co. (Upper Gwynedd, PA)
- …a profound understanding of Good Clinical Practice (GCP) with respect to digital data management (ie use of novel technology within clinical trials).Build and ... is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In collaboration with the Clinical… more
- Merck & Co. (Rahway, NJ)
- …needs. Drive the collaborative development of the technology strategy, technology standards, roadmaps, and practices. Collaborate with data analytics team ... around the use of new cloud features to establish an acceptable risk posture. Define the requirements, best practices, and lead the collaborative development… more
- Merck & Co. (Rahway, NJ)
- …space, including process flow diagrams and engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... development of clinical sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants for the assigned trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... development of clinical sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial participants for the assigned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, ... development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the assigned… more
- Merck & Co. (North Wales, PA)
- …compliance to Company, local laws and agency regulations and related guidance around technology .-Apply data stewardship and data governance principles in the ... users requiring modifications to existing systems.Approve change requests for upgrades/bug fixes/ data changes and coordinate release planning and assessment for the… more
- Merck & Co. (Rahway, NJ)
- …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. (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 ... Manual or with potential for impact on product quality, patient safety or data integrity. Work closely with stakeholders and SME's from site operations, quality… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring… 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 ... during internal and external regulatory audits (including FDA, EMEA).Support coordination of data collection and trend analysis as requested by QA and Regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position Converts Information Technology strategy into reality through execution of high priority, complex ... met. Relationships Reports to the Director, IT Project Execution. Partners with internal Information Technology colleagues as well as with Line of Business key… 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
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