- Legend Biotech USA, Inc. (Raritan, NJ)
- … initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. ... treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality ...as with all applicable regulatory requirements.Support GxP regulatory inspections as required.Support the local Compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Maintain learning management systems and track training completion rates to ensure compliance with safety and regulatory requirements Lead the development and ... for purpose learning Evaluate training curricula and make adjustments based on feedback, compliance audits, and evolving regulatory standards Key Area #2 Lead… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Quality /Training processes, systems, and resources are optimized to support regulatory compliance while enabling scalability, automation, and continuous ... is responsible for driving efficiency, quality , and innovation across US Quality , GxP Compliance Training and Patient Safety Operations. This role ensures… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... plansIndependently lead the central messaging, preparation, and submission of high quality , regulatory complaint regulatory dossiersDirect hands-on… 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
- 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality ... internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex,… more
- Aequor (Thousand Oaks, CA)
- …(R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to processes, ... Regulations and Medical Device Standards Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … advanced degree preferred 7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or ... have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry.… more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality ... advanced analytics, technology/ best practice adoption within clinical quality .Build relations with the industry-wide QA community, present, publish at… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Utilize ... systems.Ensure that all activities are conducted with the highest regard for safety, quality , and regulatory compliance , aligning with the company's… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities: Strategic ... and performance of team members, fostering a collaborative and innovative team environment. Regulatory Compliance and Quality Assurance: Ensure that all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance - Ensures that Data Management Plans… more
- Eisai, Inc (Baltimore, MD)
- …If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for ... design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the … more
- Merck & Co. (Rahway, NJ)
- …and operations to deliver capabilities that materially improve throughput, quality , flexibility and cost-to-serve for highly customized manufacturing requirements. ... complex custom orders: quoting/configuration, planning and scheduling, production execution, quality , and fulfillment. Your leadership will reduce waste, shorten… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Monitor internal workflows and performance metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical ... the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance… more
- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk… more
- Merck & Co. (Rahway, NJ)
- …to manage assurance of supply, quality , service, cost, innovation and regulatory compliance within Global or International category of spend, resulting in ... strong relationships with key leaders and stakeholders, namely External Manufacturing, Quality / Regulatory , Finance, Legal, and Shared Business Services, and… more
- Insmed Incorporated (NJ)
- …in line with expectations. Interprets and applies knowledge of regulatory / compliance /scientific requirements, using own judgment, prior work experience, ... You Are:Equivalent to 3 years of experience with an advanced degree or 5 years of experience with a...Regulatory medical writing experience is requiredMust demonstrate a high- quality writing style in the English language and have… more
