- Merck & Co. (Rahway, NJ)
- …processes and procedures (internal and external).Working knowledge of design controls and risk management processes for medical devices and combination products, ... including establishment of design inputs, design outputs, design verification, and risk management integration. Expertise in testing, characterization, and… more
- Merck & Co. (Rahway, NJ)
- …(including the CTC, CRAs and-COM).-Responsible for creating and executing a local risk management plan for assigned studies.Ensures compliance with CTMS, eTMF ... role is primarily accountable for the end-to-end performance and project management for-assigned protocols in a country in compliance with International Conference… more
- Merck & Co. (Rahway, NJ)
- …with understanding of Design Controls (21 CFR 820.30)Familiarity with the following standards: Quality Management - ISO 13485, Risk Management - ISO 14971, ... in layman's terms to facilitate cross-functional understanding.Development experience in risk -oriented, regulated environmentsDevelopment project leadership with a proven track… more
- Tris Pharma (Monmouth Junction, NJ)
- …aggregate safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent works cross-functionally with ... and oversight experience for global safety activities, operations and risk management strategies in pre and post marketing environments Expert knowledge… more
- Merck & Co. (North Wales, PA)
- …of a combination product.Review and approve Design Control and Device Risk Management documentation for regulatory filings, clinical supply, development, ... Design Controls / CAPA / Purchasing Controls as it related to 21CFR820. Risk Management experience (ISO 1497124971, ICH Q9).Effective communication skills and… more
- Aequor (Devers, TX)
- …review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must be skilled in planning and ... review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles. Must be skilled in planning and… more
- Novo Nordisk Inc. (Durham, NC)
- …of data entered to support reliability and maintenance excellence programs Lead Risk Management Planning workshops in anticipation of risks that could ... to include Reliability, Planning, Scheduling, Spare Parts, Computerized Maintenance Management System (CMMS). Responsibilities include, but are not limited to,… more
- Beth Israel Deaconess Medical Center (Boston, MA)
- …the ability to provide supervision and consultation in complex psychosocial, ethical, and risk management situations. Has a broad understanding of fiscal and ... ability to provide supervision and consultation around complex psychosocial, ethical and risk management situations. Broad understanding of fiscal and regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …security risks are effectively assessed, understood, and managed in alignment with our risk management process. The individual in this position will: Seek ... strategy. Advise system and project teams on information security procedures. Conduct risk identification and assessment with attention to the business processes and… more
- Merck & Co. (Rahway, NJ)
- …IT organizations to ensure alignment with Platform teams, IT architecture, IT Risk management , support organizations in delivering projects.Contribute as a ... Engineers, developing new solutions or enhancing existing solutions in Guest Management , Physical Access Control, and Video Surveillance products within the Site… more
