- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical or medical device/pharmaceutical combination product experience and actual regulatory experience Advanced knowledge of pertinent FDA regulations ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high- quality... Affairs, R&D, Manufacturing, and our Commercial division, ensuring compliance and accessibility of programs to patients in relevant… more
- Merck & Co. (North Wales, PA)
- …Skills:--At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biologics or vaccine Regulatory CMC, or development; ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance . Address recurring ... life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …major programs or initiatives, and may function in a project leadership role Regulatory compliance : Ensures compliance with all Federal regulations, ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ... of multiple myeloma. Legend Biotech is seeking Operations Manager- Investigations and Compliance as part of the Technical Operations team based in Raritan, NJ.… more
- Insmed Incorporated (Bridgewater, NJ)
- …the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance ... strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key … more
- Insmed Incorporated (Bridgewater, NJ)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will ... compliance requirements, work with critical suppliers to ensure quality , consistent supply.Review and monitor all lab processes to...discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …potential new metricsSupporting continuous improvement projects assigned potentially within regulatory compliance , internal/supplier auditing, or customer focus ... areas centered around rare diseases and immune disorders. Job Summary The GMP Quality Assurance Internship is a program that provides training for the intern in… more
- Merck & Co. (Rahway, NJ)
- …influences site, region and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal Health Sites located in North… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(ie cost benefit analysis, ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverable quality , and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... programming standard on datasets and TFLs to improve efficiency and quality .Responsibilities- By leading internal programming contractor or by self, perform… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Novo Nordisk Inc. (Pittsburgh, PA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …by management to check principles of assuring patient safety, data integrity and regulatory compliance are sufficient Monitor and escalate GxP compliance ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...and expectations of internal/external stakeholders, striving for simplicity, making quality a proactive consideration, ensuring compliance with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... Lead on site emergency coordinators Conduct routine safety observations to ensure compliance with regulatory agencies, company environmental, health, and safety… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …shooting and resolving complex scientific / technical problems Develops and evaluates quality processes and system standards to ensure compliance with applicable ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance , clinical quality , or cell… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and… more
