- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Insmed Incorporated (Bridgewater, NJ)
- …to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative ... study team with audits/inspections for CRO/vendors in preparation of regulatory body inspections and potential vendor contracts.Responsible for the collection… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Technician, MaintenanceThe Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… 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 of the most diverse and collaborative groups within the… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...Clinical Trial sites. Accountable for overall performance management of Senior Supply team, who contribute to the planning, execution… more
- Merck & Co. (North Wales, PA)
- …teams in order to build partnerships and trust with Commercial Legal, Compliance , Privacy and Regulatory colleagues to effectively alleviate concerns and ... Hybrid work model (combination of in-office and work from home abilities).The- Associate Director, Digital & Omnichannel Innovation for US Oncology-focuses on digital… 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. (Plainsboro, NJ)
- …marketing, market access, commercial insights and analytics, sales, medical/CMR, legal, compliance , and regulatory . Other internal relationships include Public ... Field Access, and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has high exposure to… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... cost & timely completion of all validation deliverables. Relationships Associate Director. Essential Functions Perform, review & approve validation/revalidation.… 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, ... listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration… more
- Aequor (Athens, GA)
- …plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of ... Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution...critical issues within area assigned and may escalate to senior management team based on severity of the issue.… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance , and Medical Affairs, to align and compliantly ... in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member...of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does… more
- Merck & Co. (Rahway, NJ)
- …changes and developments align with business requirements, industry standards, and regulatory compliance .Adhere to change control processes and methodologies to ... technical experience; competence in clear concise and tactful communication with senior management, clients, peers and team members. Travel Requirements: 10-15%… 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
- Merck & Co. (Rahway, NJ)
- …safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a subject matter expert in CDISC Controlled ... associated reference data to data collection and transformation specifications in compliance with Health Authority regulations and guidance and company best… more
- Ecumen - St. Benedict's Community - St. Cloud (St. Cloud, MN)
- …and CEU verification for the clinical team. Delegates tasks and monitors compliance with quality and regulatory requirements. Implements Ecumen policies and ... regulatory bodies. Collaborates with the clinical team and Senior Living Consultant(s) to facilitate resident admissions. Promotes utilization of supportive… more
