- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Novo Nordisk Inc. (WA)
- …research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance ) for monitoring and site management ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position will ... be part of the Compliance organization and will report...business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and… more
- Merck & Co. (Durham, NC)
- …will be responsible for activities that support Good Manufacturing Practice and regulatory compliance during product manufacturing within the respective VMF's to ... with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract… more
- Eisai, Inc (Nutley, NJ)
- …security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of regulatory , ... educating end-users on compliance requirements. Additionally, you manage regulatory compliance activities, maintain accurate documentation, and evaluate new… more
- Merck & Co. (Durham, NC)
- …the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team, ... shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with a team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Non-interventional, Managed Access Programs, Investigator initiated studies and Collaborative Research .Support adherence to regulatory safety requirements for ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummarySupport the PVQA… more
- Merck & Co. (North Wales, PA)
- …coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate extensively and troubleshoot issues ... Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... various contractors meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Manager , ... and ensure all projects and materials have been through the correct regulatory review process before being delivered to field sales forces.Support secondary customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The ... Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL)...next steps for strategic process update and/or information sharing.Responsibilities:GCP Compliance :Develop seamless partnerships within GCO and non-GCO functions to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and product information to ensure accurate, quality data are available Assure compliance with applicable regulatory requirements as they affect CMR Physical ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Project Manager , Accelerated Efficiencies and Optimization, will drive execution of… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Director of Research Administration and under limited direction, the Contracts Manager - Federal Contracts and Compliance , will oversee end-to-end contract ... contracts and compliance of the Office of Research Contracts (ORC).The Contracts Manager - Federal...DCA audits and prepare and file all necessary governmental regulatory reports and plans.The Manager will also… more
- Lundbeck (Omaha, NE)
- …neurology and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our ... addition to other payer channels including Medicaid and Commercial. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial ... Information Disclosure Manager leads company operational activities to comply with US,...Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the… more
- Lundbeck (Dallas, TX)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and … more
- Insmed Incorporated (San Diego, CA)
- …monitors accreditation and inspection standards, keeping the laboratory in compliance with regulatory standards.Coordinate inventory monitoring, sample, tests ... day, our employees turn their passion for science and research into innovative solutions for patients. That's why we...up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary The purpose of ... ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology… more
