- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Merck & Co. (Rahway, NJ)
- … for assigned protocols and sites in a-country.-Under the oversight of the CRA manager the person ensures compliance of study conduct with-ICH/GCP and country ... reporting requirements internally and externally.Acts as primary site contact and site manager throughout all phases of a clinical research study,-taking overall… more
- Novo Nordisk Inc. (WA)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and ... & investigations, 3rd party/vendor oversight and liaison to support audit and inspections as applicable. Support MA/PV health authority inspections… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory ... risks to an acceptable level.Manage IT compliance issue resolution.Report compliance risk levels to key stakeholders.Coordinate audit readiness and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...strategy and plan, optimizing speed, quality and budget in compliance with standard processes, policies and procedures Collaborates with… more
- Catalent (St. Petersburg, FL)
- Manager , QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... Client interface, Lab Investigations, Deviations, Complaints, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... the QA Specialists. The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this… more
- Novo Nordisk Inc. (Minneapolis, MN)
- …with field sales forces are accomplished. Essential Functions Regional account manager (ram) coaching: Ensure that RAMs understand their level of accountability ... This includes the execution of brand value propositions, including clinical , quality and health economics positioning and product specifications Direct/oversee… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …the Role:Job SummaryResponsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research: Study ... Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data...Degree.Minimum Experience: One (1) to two (2) years direct clinical RN experience. Less than one (1) year RN… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …and implement as approved.Organizes workflow and patient schedules.Routinely assists the manager with annual employee clinical competency assessments and ... processes.Ensures that staff are clinically trained in all exams and provides audit documentation.Ensures clinical excellence in monitoring chart audits, DNV… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …research studies.Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report ... of assigned grant projects.Responsible for ensuring all research stages are in compliance with all regulatory requirements as outlined in NGHS policies, local, state… more
- Option Care Health (Altoona, PA)
- …always. Naven Health is a nationwide home infusion nursing network and clinical platform focused on delivering specialized, truly exceptional infusion care. With ... services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining the Naven… more
- Option Care Health (Torrington, CT)
- …participates in facility process improvement program and assists Supervisor or Nurse Manager with chart audit functions as applicable.Performs other related ... and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health...treatment site to ensure patient safety with continuity and compliance under a physician's plan of care. Works under… more
- Option Care Health (Delaplane, VA)
- …participates in facility process improvement program and assists Supervisor or Nurse Manager with chart audit functions as applicable.Performs other related ... and chronic conditions in all 50 states. Through our clinical leadership, expertise and national scale, Option Care Health...treatment site to ensure patient safety with continuity and compliance under a physician's plan of care. Works under… more
- Healthfirst (NY)
- …audit support + Develops, implements, and monitors processes to manage routine clinical audits and ensure regulatory compliance + Advises departments on ... operational strategy to ensure alignment to compliance and regulatory requirements + Oversees development of business..., Finance, and Pharmacy to identify, understand, and process audit deliverables + Responds to regulatory actions and … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || ... technology company in the world. To help us deliver this ambition, we are recruiting a Manager of Internal Audit - Americas and Global IT Audit Leader. The… more
- Baptist Memorial (Memphis, TN)
- …education + Employee referral program Job Summary: Position: 16009 - Manager -Internal Audit Facility: BMHCC Corporate Office Department: HS Corporate ... conducting and controlling audits or reviews of the financial, operational and compliance audits, as may be required. Supervises Auditor and Senior Auditor staff… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Senior Manager Tax and Audit supports all Mitsubishi Tanabe Pharma group companies ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
