- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory ... 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… 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
- Lundbeck (New York, NY)
- …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 regulatory… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. Job Summary Oversees and assures compliance with standard operating procedures, compliance with regulatory standards and ... guidelines, and compliance with operating agreements with co-marketing partners to meet assigned timeframes and to assure consistency of case records and documentation.Responsible for evaluating, tracking, documenting and processing adverse event reports… more
- Lundbeck (Bronx, NY)
- …and psychiatry. Join us on our journey of growth!As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and ... issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of pharmaceutical and… more
- Merck & Co. (Rahway, NJ)
- …for execution and oversight of local operational clinical trial activities-in compliance with ICH/GCP and country regulations, company policies and procedures ... individual is responsible to-manage/oversee a team of CTCs(Clinical Trial Coordinator).As line manager the role is critical to continuously develop future talent by… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... operations team for the site.- The Manager will direct a team of hourly personnel who...NJ and is a 12-hour rotating shift. Position Duties: Compliance - Accountable for creating and sustaining a culture… more
- Merck & Co. (Rahway, NJ)
- …performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures, ... close out.Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our Company policies and procedures,… more
- Merck & Co. (Rahway, NJ)
- …and execute the defined processUse financial tools and ensure compliance /performance to the agreements (hold customers accountable to their commitments)Communicate ... (15%) Optimize internal data to develop strategies, monitor customer compliance , maximize ROI, identify growth opportunitiesMaintain accurate financial and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager Global Oncology Value Access & Pricing will support the market access ... providing technical support to drive the success of the ADC asset. With manager oversight, the individual will work on global, access strategy development and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with vendors to define and manage service-level agreements (SLAs), ensuring compliance and high-quality service delivery- Monitor vendor performance, conduct regular ... training program for ME vendor teams, DSI ME team including onboarding, and compliance . Ensure training program aligns with ME objectives, best practices and DSI … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions, in regions and countries for all GOMA clinical activities. Process/Policies/ Compliance Provide input to process standards and tools to achieve excellence ... in trial operations and management.Monitor and ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable ... regulatory guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(SAP).Study execution: Reviews patient demographics, enrollment, retention and protocol compliance for consistency with study strategy; reviews emerging clinical ... data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... data governance to ensure data integrity, quality, consistency, and compliance with regulatory requirements.Define data governance principles, policies, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The primary responsibilities of the Manager , Omnichannel Marketing is to support the development, planning and implementation ... customer segments across the portfolio in partnership with brand teams. The Manager should assess external digital opportunities and threats, customer journeys, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... meets Global DX Computer System Validation requirements, global regulatory compliance , and global Quality expectations. Partner with global Quality departments… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the… more
