- Daiichi Sankyo, Inc. (Bernards, NJ)
- …optimum benefit- risk for Development Sankyo's development compounds through the Safety Management Team framework. This individual will use strong leadership ... diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development...will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter ... daily strategic initiatives to standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent… more
- Merck & Co. (Rahway, NJ)
- …Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Risk Management , Clinical Studies, ... and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance Must have ... processes of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support, conducts and reports internal...in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans are aligned… more
- Merck & Co. (Rahway, NJ)
- …searchesFunction as Content Lead for one or more GPV sub-teams (eg, training, risk management , procedure management ):Establish team priorities and allocate ... Compliance, Pharmacovigilance, Pharmacy Regulation, Prioritization, Regulatory Compliance, Regulatory Reporting, Risk Communications, Risk Management , … more
- Merck & Co. (Rahway, NJ)
- …equipmentStrong working knowledge of cGMP, Quality Systems (problem, deviations, change management , etc.), Safety for operationsExperience with facility fit ... The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …access programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, ... Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. This ... Provide Quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP… more
- Merck & Co. (Durham, NC)
- …technical business processes including:- technical documentation, change control, portfolio management , risk mitigation, deviation management , technical ... - DayValid Driving License:NoHazardous Material(s):n/aRequired Skills:Adaptability, Applied Engineering, Change Management , Clinical Manufacturing, Decision Making, Innovation, Interpersonal… more
- Merck & Co. (Rahway, NJ)
- …Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the ... The principal scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices… more
- Merck & Co. (Rahway, NJ)
- …suppliers.-- The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices ... ( c GMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GD...solving skills. - Good organizational, interpersonal, writing, and time management skills - - Preferred Experience and Skills: -… more
- Merck & Co. (Rahway, NJ)
- …suppliers.-- The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices ... (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDocP).-A high level of innovation, creativity, and… more
- Merck & Co. (Rahway, NJ)
- …Engineering, Business, Cell Cultures, Cell Line Development, Cell Line Engineering, Clinical Judgment, Communication, Flux Analysis, Human Health Risk ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Rochester Regional Health (Rochester, NY)
- …BSN; valid NYS Registered Nurse License is required. + Certification in quality improvement, safety , clinical risk management or equivalent (eg, ... Job Title: Clinical Risk Management Specialist...clinical staff, leadership, and other departments (Quality, Patient Safety , Patient Relations, Security, Finance, Regulatory, Compliance, Ethics, Claims/Insurance,… more
- Baystate Health (Springfield, MA)
- …the direction of the Chief Risk Officer, the Sr Director of Clinical Safety and Risk Management is responsible for the effective operation of the ... Management Department of Baystate Health. The Sr Director of Clinical Safety and Risk Management assists the Chief Risk Officer in system risk… more
- AdventHealth (Orlando, FL)
- … management or claims field AND + Experience in process improvement/patient safety / clinical risk management /quality activities + Bachelors degree in ... 125,000 outpatients each year **The role you'll contribute:** The Clinical Risk Manager (CRM) is responsible for...CRM is responsible for integrating the risk management program into the quality and safety … more
- Sanofi Group (Cambridge, MA)
- …Informed Consent Form, study report, Integrated Summary of Safety , Summary of Clinical Safety , risk management plan, label, periodic reports ... External Safety Expert:** + Provide PV and risk management expertise to internal and external...brochures, data monitoring plans, study reports, integrated summary of safety , summary of clinical safety ,… more
- Children's Mercy Kansas City (Kansas City, MO)
- …Research and/or Evidence-Based Practice. + Participates in evaluating and promoting clinical safety and risk management + Provides for education of the ... lives of children beyond the walls of our hospital. Overview The Clinical Supervisor organizes, and directs all assigned resources, including people, equipment, and… more
- Trinity Health (Albany, NY)
- … Management Analyst is responsible for the overall patient safety and clinical risk management functions related to review and response to reported ... events. Responds to crisis situations that have patient safety and risk management implications...and negotiation skills. **WORK ENVIRONMENT AND HAZARDS:** Office and/or Clinical Setting. Exposure Class I or II - dependent… more
- Rochester Regional Health (Rochester, NY)
- …BSN; valid NYS Registered Nurse License is required. + Certification in quality improvement, safety , clinical risk management or equivalent (eg, ... direct resource with clinical and technical expertise to departments. The Patient Safety Specialist works with teams to ensure the highest possible level of … more
