- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of the Quality team based in Raritan, NJ. Role OverviewThe QC Data Reviewer is an exempt level position responsible for reviewing all data produced by the ... commercial operations in a controlled GMP environment.Key Responsibilities Perform peer review /approval of laboratory data including but not limited to eLIMS… more
- University of Maryland Medical System (Baltimore, MD)
- …mean it. UMMC Midtown Campus, one of two campuses of the University of Maryland Medical Center, has had a long history of working to keep our community healthy and ... grown to become a trusted teaching hospital. We provide a broad array of medical , surgical and behavioral health care serving Baltimore City and the region. At… 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
- University of Maryland Medical System (Baltimore, MD)
- …patients to help eliminate fears/concerns and interviews patient to obtain required medical information to ensure safety during procedure. Makes proper ... patients to help eliminate fears/concerns and interviews patient to obtain required medical information to ensure safety during procedure. Makes proper… more
- University of Maryland Medical System (Baltimore, MD)
- Company Description THE MEDICAL HEART OF MARYLAND Treating over 330,000 patients every year, the University of Maryland Medical Center is at the vital core of ... evaluating, and disseminating results. 3. Monitors patient and unit safety standards; actively contributes to development and implementation of improvement… 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
- 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)
- …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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Plan (IDRP)- 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
- 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
- Novo Nordisk Inc. (Boulder, CO)
- …TRU Boulder facility complies with all applicable environmental, health and safety regulations. Relationships Reports to Associate Director, EHS at US headquarters ... valued vendors. Essential Functions Manage the maintenance and implementation of safety programs, compliance plans, and initiatives with primary focus on… more
- Merck & Co. (North Wales, PA)
- …worldwide to engage on statistical issues associated with the ongoing aggregate review of safety .-Prepare oral or written reports to effectively communicate ... analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent… more
- Merck & Co. (North Wales, PA)
- …regulatory agencies worldwide to engage on statistical issues associated with the aggregate review of safety .-May represent Clinical Safety Statistics on ... analysis methods fundamental to effective pharmaceutical R&D. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent… more
- University of Maryland Medical System (Hanover, MD)
- Company Description Experience the highest level of appreciation at UM Baltimore Washington Medical Center - named Top Workplace in the Baltimore area by The ... 2021! As part of the acclaimed University of Maryland Medical System, our facility is one of three ANCC...Quality Indicators (NSQI), National Hospital Quality Measures, National Patient Safety Goals, HCAHPS and contributes to unit initiatives to… more
- University of Maryland Medical System (Baltimore, MD)
- Company Description THE MEDICAL HEART OF MARYLAND Treating over 330,000 patients every year, the University of Maryland Medical Center is at the vital core of ... position (7AM-7:30PM). Every third weekend. Baltimore, MD At the University of Maryland Medical Center (UMMC), a designated Magnet facility, we are a team. Nurses… 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
