- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all ... review, tracking of milestones as per contract). Ensure the global clinical operations systems for management of...activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality .Establish… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... activities pertaining to clinical trials, including but not limited to: data management...Works with management to maintain the consistent execution of quality global procedures. If applicable, monitors workload… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... design and monitoring of clinical programs and studies, producing high- quality clinical documents and presentations.Collaborate with functional area leaders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory ... on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in...regulatory strategy for assigned programs to ensure timely and high- quality regulatory deliverables to the GPTs Lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Future Business Strategy (FBS), Strategic Operations (SO, Human Resources. Key global stakeholders include: various stakeholders within Clinical Drug Development ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / Clinical Quality Management or other RD business ... research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy...and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality… more
- Merck & Co. (Rahway, NJ)
- …scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Process Engineer… more
- Merck & Co. (Rahway, NJ)
- … Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and ... with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Within the Global Development organization this is a key new role to lead the Clinical Operations function across our Boston, MA and Princeton, NJ campuses ... well as ensuring close collaboration with other areas of Global Development and US Clinical , Medical and...Is responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverables Provide… more
- Merck & Co. (North Wales, PA)
- …process owners in GCD and GCTO like our company's IT, Medical Monitors, Clinical Scientists, Clinical Quality Operations Managers (CQOMs), GDMS, BARDS ... Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the...in clinical research (eg, monitoring, data management, clinical quality assurance, study management)Experience with risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi... clinical data regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review… more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and protocol compliance for consistency with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... into CDP planning and individual protocols to facilitate successful implementation of programs. Clinical OperationsEnsure high quality delivery of all studies for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Director, Clinical Safety, will be a product safety lead or part of a ... role may function as a key member of the Global Product Team in collaboration with Clinical ...Depending on the status of development of the compound, lead and medical-scientifically direct a team of junior physicians… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partners. They will also develop, oversee, and manage implementation of global labeling development and quality review processes, templates, metrics, ... launch activities by partnering closely with Supply Chain Technical Operations teams and Global Regulatory Leads to release high quality labeling components in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the ... teams on RA labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
