- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …supply chain of internal and external GMP manufacturing organizations.Ensures a satisfactory regulatory compliance level for these organizations for local and ... collaboration with Global External Supplier QA teams.Collaborate with Global Quality Management System (QMS) teams on regulatory -related...to recommend metrics and report the state of GMP Quality and compliance of Daiichi Sankyo and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head ... resolution.Proactively ensure that all functions consistently operate in a state of compliance .Facilitate the implementation of the quality strategy in close… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and outside ... compliance , vendor oversight importance (ICH E6(R2) requirements), and regulatory inspection-readiness.Ensure alignment on CRO/Vendor oversight standard practices across… more
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferredExperience with process mapping tools (eg, Visio, Power Point), and Veeva Quality Docs requiredUnderstanding of regulatory and industry guidance and ... areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership and Life Cycle… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …hires during on-boarding and provide on-going support, as determined by Field Director Ensure personal compliance with all internal/external SOPs/rules and ... 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)
- …all team activities are completed with the highest regard for safety, quality and regulatory compliance .Qualifications:Education Minimum Requirement: This ... Job DescriptionDirector, Chemical Biotechnologies Description:The Director of Chemical Biotechnologies reports to the Senior Director Chemical Biotechnologies in… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...product development, control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational ... efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology. Work with the business users… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …due diligence activities during the vendor selection process.Close partnership with clinical quality management, SVO and other compliance functions within and ... effectiveness measures.Ensures appropriate oversight from a clinical trial risk and compliance standpoint and establishes a comprehensive interface for risk and… 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 ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Merck & Co. (Durham, NC)
- …work environment with optimized product quality and manufacturing processes and regulatory compliance .Lead the Facilities Maintenance and IFM program for the ... and temporary project personnel. -Reports to the site's Executive Director of Engineering, Maintenance and Site Services.GENERAL PROFILE:VMF Maintenance:Lead the… more
- Merck & Co. (Rahway, NJ)
- …CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing is essential.The successful ... and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …templates Serve as an SME for global initiatives related to quality / compliance /validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring ... the treatment of multiple myeloma. Legend Biotech is seeking Director , Global Process Validation as part of the Technical...participation in a variety of cross functional CMC and quality forum under the Joint Manufacturing Committee in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... 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)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population...SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking of labeling milestones. Collaborate with Global Labeling Operations and Compliance leads to product high quality labeling documentation.Establishes ... tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Insmed Incorporated (San Diego, CA)
- …York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Program Management, the Associate Director , Program Management ... and will drive the development, creation, and implementation of high quality , global, coordinated cross-functional project plans for products in accordance with… more
