- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Sr. QC Data Reviewer as part of the Quality team based in Raritan, NJ.Role OverviewThe QC Data ... Reviewer is an exempt level position responsible for reviewing...operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Data Reviewer as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QC Microbiology Data Reviewer is an exempt level position with responsibilities for...and commercial operations in a controlled cGMP cleanroom environment.Create, review and approve relevant QC documents, logbooks, SOP's and… more
- Spectraforce Technologies Inc (Atlanta, GA)
- …Team Lead and other client personnel to perform quality assurance reviews on medical records. The HEDIS Quality Assurance Nurse Reviewer will validate abstracted ... Title: Quality Assurance Nurse Reviewer (Overread Team), (100% Remote) Duration: 5 Months...other duties toward HEDIS collection as assigned including HEDIS medical record review and outreach for collection… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to writing minor safety sections of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful candidates ... relevant medical topics, and supports PV Operations' medical review function. This position supports a...medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing… more
- UT Health Tyler (Tyler, TX)
- …focus areas regarding Quality Monitoring and Improvement, Regulatory Compliance, Patient Safety , Risk Management, Medical Staff Services and Practice ... advancing healthcare, together. POSITION SUMMARY The position of Quality and Patient Safety Director at UTHET is accountable for assisting the organization to… more
- University Medical Center of El Paso (El Paso, TX)
- Job Summary: The Second Level Reviewer Registered Nurse plays a pivotal role in conducting critical, high-risk and intricate secondary case reviews that are ... organizational standards, enhancing continuity of care and overall patient safety while meeting regulatory compliance requirements. Minimum Job Requirements: Work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to achieve marketing's goals. Learn the core fundamentals of Medical Accuracy Review and Medical Review in an assigned therapeutic area(s). Participate ... global alignment of medical information standards and best practices. Medical Promotional Review (option) Gain an understanding of Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, ... FTE allocation, budget allocation, and assessment of needs including training, data review tools, etc. Standing PRG reviewer for mid-to-late-stage asset… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, ... medical history, and medications when needed- Addresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narratives- May lead the development and updates of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, ... AEs, medical history, and medications when neededAddresses medical questions directly from sites/ Institutional Review ...review tables, listings, and figures (TLF) and CSR safety narrativesMay lead the development and updates of the… more
- On-Board Companies (Greenville, SC)
- …in the fieldBenefits: Paid time off, paid holidays and health benefits: Medical , Dental, Vision, aggressive 401K match and Life InsuranceCompensation: $120,000 - ... packageBased on eligibility, role and job status, we offer many programs including medical , dental, vision, life insurance, 401(k) plan, paid time off and holidays,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fellow will have regular contact with cross functional areas including: Commercial, Safety , Medical , Clinical Operations, and Legal. This structured approach ... skills, both oral, written and presentation.Demonstrate an ability to perform medical accuracy review with strong attention to detail.Proficiency in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and is member of the Product Labelling Committee (PLC) Review Group Review /approve deliverables of the safety surveillance team Safety surveillance of ... functions Conduct product training within therapeutic area of responsibility Review /approve deliverables of the safety surveillance team Chairmanship/membership… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with ... workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and labels… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for marketed products and is member of the Product Labelling Committee (PLC) Review Group Safety surveillance of Novo Nordisk products during pre-approval and ... a difference? The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the US… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support:… more
- The George Washington University (Washington, DC)
- …the outcome of any of the aforementioned inspections. Provide technical expertise in the review of any safety controls and practices to be implemented or ... of everyone within the GW community.Reporting to the Director of Environmental Health and Safety (EHS) with daily coordination and support to the Office of Research … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …generation strategies and activities as part of the USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies ... of a US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across USOMA functions to develop, review , and align on key… more
- Flex-N-Gate Corporation (Grand Rapids, MI)
- …provincial, and federal OHSA requirements.Coordinate inspections, investigations, and occupational safety activities with departments.Direct and review the ... opportunity for hard-working and skilled individuals. Scope of the Position Health & Safety (H&S) Coordinator is responsible for performing H&S related duties on a… more
- Uline (Irving, TX)
- …ensure our program meets both legal requirements and Uline's standards.Drive continuous safety improvements, audit work areas, review incident reports and ... a state or federal level preferred.Worker's compensation and Environmental Health and Safety (EHS) experience a plus. BenefitsComplete medical , dental, vision… more
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