- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III … more
- Catalent (San Diego, CA)
- …Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the ... Reviews, etc. and oversee and execute all Performance Management Program (PMP) actions for the site Quality ...quality issues to Site Leadership Team and QA senior management.Lead programs for: QA department budget, Site Training,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to lead, support and report independent GCP audits according to Novo Nordisk quality systems, Good Clinical Practice (GCP) and current international and national ... About the Department Every day, millions of people rely on the quality and safety of our products. The Novo Nordisk Quality Management System (QMS) enables us to… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the transition of the TMF to Insmed at end of study. Partner with Quality Assurance team to help clinical study team with audits/inspections for CRO/vendors ... and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solutions to mitigate or resolve, for example across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, ... as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/global quality projects to improve the … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and agility Is responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverables Provide continuous assessment and ... clinical operations functions to ensure efficiency, effectiveness, and quality -by-design in operational execution; accountable for maintaining pro-active approach… more
- Merck & Co. (Rahway, NJ)
- …within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality Managers (CQMs).Engage with Functional Service Provider (FSP) ... in our headquarters. Additionally, there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory, Clinical Supplies and legal in a… more
- Merck & Co. (Rahway, NJ)
- …health.This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Eisai, Inc (NJ)
- …As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of ... If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4… more
- Merck & Co. (North Wales, PA)
- …is to lead the coordination and execution of major change projects across Global Clinical Trial Operations. The role will also assist with Program Management ... adapt plans based on evolving needs to ensure on-time, high- quality delivery in accordance with the stated project goals.Ensure...are updated and readily available for internal teams and senior leaders. Upon completion of a project, the PMO… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team on an as needed basis. Relationships Reports to the VP, Regulatory, Quality & Clinical Reporting, East Coast Global Development Hub. Essential Functions ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical ... the clinical operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure a strong focus on competencies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Merck & Co. (Rahway, NJ)
- …safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, ... statistical analysis and high- quality data to support decision making in ...assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... Plan, manage & perform validation activities at the Boulder Pilot and Clinical GMP Plants. Handle simple to moderate complexity validation projects. Support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along ... point person for all GxP matters for the Global Program Head and the Global Program Team....ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality … more
- Catalent (Harman, WV)
- …, audits and inspections, raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality ... POSITION SUMMARY The Director, Quality Systems is responsible for the management and...track completion of risk assessmentsCompile pertinent QA metrics for Senior Management reviewAssemble critical metrics from applicable departments, analyze… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
