- Merck & Co. (Rahway, NJ)
- …surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies.Utilize statistical methods to interpret ... Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial... risk data , providing clear and actionable recommendations rooted in empirical… more
- 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
- Insmed Incorporated (NJ)
- …you have:Knowledge in negotiation of clinical trial agreements, regulatory matters, risk management and contract management .Experience in contract, ... in the achievement of successful outcomes.Assist in d ata management of data points from the review...range of issues related to clinical development, clinical operations and risk management .Extensive… more
- Insmed Incorporated (NJ)
- …throughout the system lifecycle.Evaluate and manage third-party vendors and SaaS/cloud-based clinical systems for compliance with data integrity and ... and archival procedures meet both regulatory and company policies.Provide project management support for clinical system implementations, upgrades, ensuring… more
- Insmed Incorporated (NJ)
- …needs and inform future negotiations.Monitor market trends, compliance requirements and risk factors related to clinical operations.Track and analyze spend ... will be responsible for managing the indirect procurement activities within the Clinical Operations category. This role will be instrumental in facilitating sourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology, and other… more
- Sunrise Senior Living (Bethesda, MD)
- …of care team members. Quality Assurance and Regulatory Compliance Track, trend, and report clinical quality data to identify risk . Participate actively as a ... clinical performance data preferred Experience in quality and clinical process improvement and risk assessment preferred Experience in staff development,… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... Job DescriptionThe Director, Technical Operations within Global Clinical Supply (GCS) is responsible for technical leadership in support of GCS global facilities and… more
- Sunrise Senior Living (Mclean, VA)
- …of care team members. Quality Assurance & Regulatory Compliance Track, trend and report clinical quality data to identify risk . Actively participate as a ... leadership team to promote resident safety and compliance with Risk Management and OSHA programs. Serves as...performance data preferred. Experience in quality and clinical process improvement and risk assessment preferred.… more
- Insmed Incorporated (NJ)
- …the Senior Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for ... You'll also:Be responsible for appropriate review of all safety data from various sources (eg pre- clinical , ...Company Core Data Sheet, Investigator's Brochure and Risk Management Plans (RMPs), and Risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO, feasibility team and the study team.Assist Data Management with development of the clinical database (edit checks, CCG development, ... 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… more
- Sunrise Senior Living (Silver Spring, MD)
- …and learn about pertinent information and any resident's physical and behavioral changes. Risk Management and General Safety Partner with community team to ... national/provincial regulations pertaining to occupational health and safety requirements, promoting Risk Management programs and policies and adhering to safety… more
- Eisai, Inc (Nutley, NJ)
- …issues arising from commercial and medical review committee submissions. Advise on cross-border data transfers (eg, clinical data ) and collaborate with ... Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder… more
- Bayer (WA)
- … trial team and engaging with appropriate stakeholders for Bayer sponsored clinical trials. Support with data collection, feasibility & initiation visits, ... in the medical community through the dissemination of and education on scientific data related to Bayer products across the product lifecycle. The MSL establishes… more
- Bayer (Nashville, TN)
- … trial team and engaging with appropriate stakeholders for Bayer sponsored clinical trials. Support with data collection, feasibility & initiation visits, ... in the medical community through the dissemination of and education on scientific data related to Bayer products across the product lifecycle. The MSL establishes… more
- Merck & Co. (Rahway, NJ)
- …development effort of other programmers; experience as a programming mentorFamiliarity with statistics, clinical and data management concepts as applied to ... Skills: Accountability, Clinical Development, Computer Science, Database Management Systems (DBMS), Data Management , … more
- Merck & Co. (Rahway, NJ)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying ... of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to apply… 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 ... 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)
- …O3Job Family: Manuf/OperationsSenior Technician, OperationsPharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for ... and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms.- Positions will support development and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME… more
