- Insmed Incorporated (NJ)
- …Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for ... safety surveillance, risk management , and risk communication...global PV regulations and applicable ICH guidelines.Experience in preparing clinical safety assessments and regulatory reports/submissions involving… more
- 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 ... rare diseases and immune disorders. Summary: The Senior Director, Clinical Safety , will lead the development and...will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the… more
- Bayer (Whippany, NJ)
- …commercialization, and maintenance of product licenses (eg, Core Data Sheet, Periodic Safety Update Report, clinical benefit- risk assessment for license ... renewals) for the compound(s);Lead the matrix- management of clinical trial teams, collaborating across the organization and externally with service providers and… more
- Eisai, Inc (Miami, FL)
- …initiatives, ensuring timely, high-quality deliverables aligned with industry best practices. Risk Management & Problem Solving Evaluate analytical options, ... experimental therapies. May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.… more
- Merck & Co. (Rahway, NJ)
- …with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to ... Job DescriptionThe Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership...operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support the future… more
- University of New Mexico - Hospitals (Rio Rancho, NM)
- …psychosocial evaluation/assessment, diagnostic, counseling therapy, crisis intervention, and/or case management services in a high-intensity clinical environment ... of a variety of matters * TRAINING - Provide clinical supervision to lower level therapists and/or graduate social...and/or situations that may put a patient at undue risk * PATIENT SAFETY 4 - Report… 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 ... leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are… more
- University of New Mexico - Hospitals (Albuquerque, NM)
- …professional organizations/associations to stay current as to relevant national standards of clinical care, patient safety and innovation in healthcare quality; ... FTE: 1.00 Full Time Shift: Days Position Summary: The Perinatal Quality and Safety Specialist (PQSS) is dedicated to improving maternal and neonatal outcomes by… more
- Merck & Co. (Rahway, NJ)
- …Efficiencies, Production Process Development, Production Scheduling, Raw Material Sampling, Risk Control Assessment, Safety Protocols {+ 5 more}Preferred ... (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant under construction in Rahway, New Jersey. They… more
- Merck & Co. (Rahway, NJ)
- …closely with team members and partner groups including formulators, engineers, Quality, Safety , and Facilities management to drive overall success and ... safety , and process deviations as appropriate while notifying management .- Able to redline SOPS for continuous improvement.Supports investigations and… more
- Merck & Co. (Rahway, NJ)
- …Monitoring, Pharmaceutical Manufacturing, Preventive Maintenance, Process Optimization, Production Standards, Risk Management {+ 4 more}Preferred Skills: Current ... Job DescriptionThe Associate Director, Automation within Global Clinical Supply (GCS) is responsible for developing and executing a systems and process automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Quality, Safety , Compliance, IT based on business understanding and risk assessment; collaborate with requesting business stakeholders as needed Triage special ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… 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.Support manufacturing activities for cGMP compliance through spot… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- ….Participate in the development of target product profiles and preclinical safety packages to support clinical development and commercial strategy.Collaborate ... closely with internal functions such as Pharmacology, CMC, Regulatory Affairs, Clinical , and Program Management .Maintain up-to-date knowledge of evolving… more
- Formation Bio (New York, NY)
- …for and participation in regulatory inspections and due diligence audits Apply risk management principles (eg, FMEA) to guide decision-making Champion a ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… 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
- University of New Mexico - Hospitals (Albuquerque, NM)
- …and report/correct environmental conditions and/or situations that may put a patient at undue risk * PATIENT SAFETY 4 - Report potential or actual patient ... of patients. Perform as a unit educator while maintaining clinical skills by performing as a clinical ...and caregivers with educational needs, problem solving, and health management aspects across the continuum of care * COLLABORATE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will ... oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a… more
- University of New Mexico - Hospitals (Albuquerque, NM)
- …psychosocial evaluation/assessment, diagnostic, counseling therapy, crisis intervention, and/or case management services in a high-intensity clinical environment ... Counselor Social Worker & Clinical You can get further details about the...and walk-in counseling. Clinic works collaboratively with psychiatry, medication management , medication for opiate use disorders, primary care and… more
- University of New Mexico - Hospitals (Albuquerque, NM)
- …and report/correct environmental conditions and/or situations that may put a patient at undue risk * PATIENT SAFETY 4 - Report potential or actual patient ... We are seeking passionate individuals who will work in collaboration with clinical teams to achieve quality outcomes for patients within our local communities.… more
