- Merck & Co. (Rahway, NJ)
- …lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines, strategies ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable...for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director , Clinical Operations (Asset Lead) is fully informed of the overall ... organization. This will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of ... 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head...of regulatory guidelines across all manufacturing areas, supporting both clinical and commercial sites. This individual will be a… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... QC data or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other departments… more
- BeOne Medicines (San Mateo, CA)
- … Solutions include, but are not limited to CTMS, Site Payments, RBQM, IRT, Clinical Supplies , SUSAR reporting, Clinical Operations reporting / dashboards, ... **General Description:** The Director of Digital Clinical Operations Solutions...management system requirements and standards in alignment with stakeholders ( Clinical Operations, Data Management, Supply Chain, etc.)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Novo Nordisk Inc. (Boulder, CO)
- …be an example for a drug product team that is responsible for ensuring clinical supply using aseptic manufacturing Identify and work with formulation development ... Development, Program Management, Regulatory, Analytical Development, Materials Management, and Clinical Supply Write, review, and/or approve Standard Operating… more
- Merck & Co. (Rahway, NJ)
- …and other team members to ensure the quality and safe delivery of clinical supplies , the scientific rigor of the processes, and enable flexibility and speed ... which enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees… more
- Merck & Co. (Rahway, NJ)
- …and sterile manufacturing.- This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust ... formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality , Pharmaceutical Operations,… more
- Merck & Co. (Rahway, NJ)
- …carry out analytical GMP activities partnering across the network to enable clinical supplies . In this role, the Director of the Raw Materials and Medical ... product release testing across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address ... areas centered around rare diseases and immune disorders. Summary The Executive Director , Data Management (Head of Global Data Management) sets the vision,… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Biosciences, Companion Diagnostic/Diagnostic, and Developmental Sciences and Clinical Supply . Co-chair licensing committee meetings and ... that grow our portfolio in meaningful ways. - The Director , Business Development & Licensing - Enabling Technologies Search...integration of internal subject matter expert input and the quality of formal due diligence output. Work closely with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other ... Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- GRAIL (Durham, NC)
- …Manufacturing Operations, Clinical Laboratory Operations, Program Management, Supply Chain, Materials Management, Process Engineering, Supplier Quality ... are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science...visit grail.com . As a key member of the Quality Leadership Team, the Director of … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and tracking as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (eg, disproportionality ... 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Merck & Co. (Rahway, NJ)
- …NDAs, BLAs, etc.) for combination product programs under your leadership.Lead/ Support clinical supplies production with respect to device component and ... and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… more
- Programmable Medicine Operatin (Redwood City, CA)
- …team meetings and sub-team meetings with Clinical Operations, Clinical , Clinical Supply Chian, Quality Assurance, and Regulatory Affairs Responsible ... We are seeking an experienced individual to manage uninterrupted manufacturing of Clinical Supply and eventual commercial products through execution of… more
- Jobleads-US (Roseville, CA)
- …direction and evaluation of the facility's educational programs for all employees and quality assurance and improvement in the facility. Director of Staff ... and supervision of the Administrator and through consultation and cooperation with the Director of Nurses, the Director of Staff Development Registered Nurse… more
