- 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 This role ... support the leader in the development and implementation of the Compliance Monitoring Program, specifically Federal healthcare laws, FDA promotional guidelines, and… 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 Associate ... guidelines, and policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for the creation, management, and documentation… 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. SummaryThis is an ... and ensures that material is fully released prior to shipment to siteEnsures compliance with all domestic and foreign regulatory requirements but may seek line… 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 Responsible for managing ... business teams introducing improved systems experience, cost savings, and compliance .- Stakeholder CollaborationAdvocate for the Global HRIS and collaborate with… 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 Assist in planning ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good Clinical… 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 ... Associate Director, Field Medical Training will be responsible for...technological systems to facilitate activity/workload reporting, knowledge management and compliance management Qualifications: Successful candidates will be able to… 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 Associate ... alliance forecasts as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance Committee Finance… more
- Merck & Co. (Rahway, NJ)
- …ensure strong monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is ... responsible to manage a team of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict adherence to local… 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 This position ... by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for… 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. ResponsibilitiesEnsure global ... authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and… 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 Position manages ... the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal standards, Good Clinical Practices… 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 ... Associate Director Global Medical Affairs Oncology (GMA), under the...as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities… 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 position will ... and within budget. The position may also collaborate with CROs (Clinical Research Organizations) and manage oversight. The position will partner with internal and… more
- Merck & Co. (Rahway, NJ)
- …completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses. -The Associate Principal Programmer will ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our companies renowned Research and Development… more
- Merck & Co. (Rahway, NJ)
- …Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal ... to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description The Associate Director, Technical Operations within Global Clinical Supply (GCS) is responsible for managing all aspects of ... solid dosage forms, secondary packaging of vaccines/biologics, medical devices).Strong compliance mindset and understanding of cGMP.Demonstrated strong project leadership… more
- Merck & Co. (Rahway, NJ)
- …new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be responsible for delivering SAP solutions to our ... Research Organizations' Global Clinical and Ancillary Supply-user community. You...for solution design for planning, warehouse operations, distribution, ensuring compliance with market requirements as global regulatory requirements continue… more
- Merck & Co. (Rahway, NJ)
- …SAP capabilities and technologies. As the Clinical Manufacturing Delivery Lead for our Research & Development Division , you will be responsible for delivering SAP ... for manufacturing, warehouse operations, distribution, and --reporting to ensure compliance --as business strategies and requirements continue to evolve. Develops… 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, ... Study Associates, under the guidance of the Associate Director, will supervise a group of Study Associates...the study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the study… 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 incumbent ... role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may… more
