- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- 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 ... in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a living. Are you ready to make a difference? The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of the ... clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The… more
- BioAgilytix (Boston, MA)
- …organizational success and meets business needs.Essential Responsibilities- Assist with review and approval of computerized system validations and equipment ... 11, Annex 15, CLIA and GAMPs- Perform the quality review of equipment SOPs, policies and validation master plans...require working in a laboratory setting, while following relevant safety protocolsPhysical Demands- Ability to work in an upright… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... development team. This individual will be the primary point person for medical monitoring and oversight of assigned clinical programs including monitoring of… 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 ... involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets… more
