- Insmed Incorporated (NJ)
- …We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role ... requirements while maintaining operational excellence. The Executive Director, Cybersecurity & Risk Management plays a critical leadership role in safeguarding… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... provide overall leadership and strategic direction for the clinical project management functions in a technology -driven, AI-focused biotech environment. This… more
- Formation Bio (New York, NY)
- …tools to streamline workflows and accelerate decision-making. Drive cross-functional planning, risk management , and clear action tracking. Flex Capacity ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires deep expertise in privacy law, strong communication and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …file is complete and accurate for assigned stud(ies).Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise...trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT),… 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, T-cell ... NJ.Role OverviewThe MES Project Manager will be part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Merck & Co. (Rahway, NJ)
- …Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk Management {+ 4 more}Preferred Skills: Current ... of new operational facilities and equipmentLead system-related aspects of new technology deployment such as system development lifecycle (SDLC), assessments of data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... of people globally by leveraging our world-class science and technology . With more than 125 years of scientific expertise... risk management activities completion for vendors and to periodically review… more
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug… more
