- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. 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
- 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)
- …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
- Merck & Co. (North Wales, PA)
- …of one or more clinical trials in the lung cancer program. Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical ... technical skills, and scientific acumen as part of a global , cross-functional team.Job ResponsibilitiesResponsible for specific clinical /scientific activities… more
- Eisai, Inc (NJ)
- …service providers and managing service provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance ... strategies. Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor… 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)
- … research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.Excellent understanding of Global , Country/Regional ... with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.… 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)
- …setting, to drive the development of potential products and drug candidates. The Manager, Clinical Pharmacology will support or take the lead on generation of ... with external CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug… 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)
- …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
- 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
- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- ... products and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead … 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 ... around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical … 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
- Catalent (Manassas, VA)
- …suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in accordance with templates and liaise with ... Quality Auditor Position Summary: Catalent is a global , high-growth, public company, and a leading partner for...quality teams globally during the management of supplier quality issues Lead and support Supplier issues… more
