- Daiichi Sankyo, Inc. (Bernards, NJ)
- … activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... operations expertise including first-hand knowledge of drug manufacturing, packaging, QA, compliance and audit , or equivalent experience.Must have expertise with… more
- 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. ... required).Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as with all applicable… more
- Insmed Incorporated (NJ)
- …responsible for creating and implementing programs that ensure workplace safety, regulatory compliance , and environmental protection for all Insmed locations.Key ... consultants for instruction in subjects relating to health and safety and regulatory compliance (laws, regulations, requirements). Ensuring the proper execution… more
- Insmed Incorporated (NJ)
- …review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality ... the future of science, we're in. Are you?About the Role:The Associate Director , Medical Review Committee (MRC) Operations is responsible for managing the operational… more
- Insmed Incorporated (NJ)
- …(CSV) program. This role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The ... Management and Boards of Directors .Strong understanding of risk management, compliance , and audit processes within regulated industries, ideally biotechnology… more
- Insmed Incorporated (NJ)
- …Clinical Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during ... and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, ... publishing and document management within Veeva Submissions Vault, ensuring accuracy, compliance , and timely delivery of submissions to regulatory agencies.What… more
- Port Authority of New York and New Jersey (Jersey City, NJ)
- …the Program Director is responsible for developing and executing an audit plan for business processes, operations, and functions as well as technology/systems ... act as second-line manager overseeing three divisions, each staffed with approximately 12 audit professionals. The Program Director will assist the Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to maximize your potential with us? The Position Assist Director of Institutional Contracts in managing the development and implementation of 340B as ... well as Inflation Reduction Act ("IRA") processes and compliance activities for the Medicare Drug Negotiation Program. Ensures accurate and timely input and… more
- Organon & Co. (Jersey City, NJ)
- …is achieved through close collaboration with key stakeholders in Commercial, Legal, Compliance , Privacy, Procurement, Business Technology, Quality & Audit , and ... with Global, Regional and Market level stakeholders including Commercial, Legal, Compliance , Quality & Audit , Privacy, Pharmacovigilance, and other associated… more
