- Sunrise Senior Living (Columbus, OH)
- …job description and understand the key essential duties for safety and regulatory compliance . Qualifications Sunrise Senior Living has championed quality of ... Overview The LPN Medication Care Manager is responsible for providing the highest degree...Partners with community team to ensure community is in compliance with OSHA/British Columbia Workers Compensation Act and Occupational… more
- 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
- BioAgilytix (Durham, NC)
- …in the update, enhancement, and creation of internal policies and proceduresSupports regulatory compliance to ISO, FDA, and other worldwide regulatory ... you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... to data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Aequor (Newbury Park, CA)
- …archival systems/electronic document repositories also useful. Coordination and execution of regulatory submissions in compliance with corporate standards and ... and deliverables. Works under under the direction of a Global or US Regulatory Lead or Manager and will assist in the creation and submission of regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. SummaryThis position will be part of the Compliance organization and will report directly to the Director, Compliance ... be responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This… 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
- 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
- Merck & Co. (Rahway, NJ)
- …1)-low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or- compliance issues, 4) working with regulatory issues and the broader ... Job DescriptionPosition Description: Clinical Research Manager (CRM) - General Medicine (REMOTE) This role is primarily accountable for the end-to-end performance… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …considered for all Medical Affairs programs. Interact with legal and compliance as required. Proactively collaborate with other GxP quality representatives and ... adequate systems and process support, including facilitation of respective regulatory inspection preparation, management and follow-up in collaboration with impacted… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply with US, EU, Japan ... Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with current disclosure requirements and participates in the strategic… more
- Eisai, Inc (Nutley, NJ)
- …Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and guidelines, and compliance with ... and summary reports for submission to the FDA and International Regulatory authorities.Interface with other Eisai Departments and affiliates for dissemination of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Management, as necessary.Participates in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.Remain informed… more
- Merck & Co. (Durham, NC)
- …Controllers (PLC), robotics)Maintenance Equipment (eg tools and calibration equipment) Compliance : Ensure that maintenance activities are executed in compliance ... determine root cause, and implement robust CAPAs for any team related compliance discrepancies noted during day-to-day activities and/or audits. -Escalate as per IPT… 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. (Raleigh, NC)
- …for effectively managing budget within targets Responsible for ensuring and tracking compliance with regulatory /legal mandates Review and audit direct reports' ... with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial… more
