- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects. Candidates ... clinical trial management, with firsthand experience managing collaborative research studies being highly desirable. Responsibilities:Lifecycle Management: Oversee and manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and internal education, publications, scientific exchange and external data communication , and stakeholder scientific engagement. Responsible for managing budgets ... as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Communications and Publications: Drive publication planning and medical communication activities in collaboration with GMA Medical Communication members, ... the global brand strategy development and also secure medical accuracy for communications and materials that are relevant for global by conducting scientific review… more
- Eisai, Inc (Nutley, NJ)
- …product(s) and execution of HEOR and RWE research for the development and communication of product value data to support Eisai business. This role primarily focuses ... team in customer research activities and development of external communication materials. The Director facilitates coverage, reimbursement and appropriate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will be responsible for end-to-end process for CDx Implementation in clinical studies . They will ensure that sample testing and data generation activities are ... of the CDx testing. They will also support CDx analytical and clinical validation studies in collaboration with Dx partner, or other supplemental studies to… more
- Merck & Co. (North Wales, PA)
- …for investigational or marketed vaccinesAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs and internal and external expert… more
- Merck & Co. (North Wales, PA)
- …investigational or marketed Oncology drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... the activities of Clinical Scientists in the execution of clinical studies ;Work closely with a cross-functional group of experts in commercialization, regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(from an accredited college or university)- Bachelor's Degree Computer Science, Marketing, Communications or a related field from an accredited college or university ... Data Management Body of Knowledge (DMBOK2) required- 4 or More Years Excellent communications skills (written, verbal) to express complex points to a variety of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the internal and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilitiesMedical Monitoring- For studies in which Medical Monitoring activities are conducted in-house:-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the internal and external network. Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities. Provides medical and ... scientific expertise to cross-functional DSI colleaguesResponsibilities Medical Monitoring: For studies in which Medical Monitoring activities are conducted in-house:Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices ... and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and… more
- Merck & Co. (North Wales, PA)
- …or marketed Oncology drugs;-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities at the global level. Support through open and effective communication and business partnering the cross-functional implementation of the Vision and ... to design the audit framework globally for Research area, specifically GLP/GCLP studies .Partners with Audit and Compliance QA function to develop compliance and risk… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management including activities related to evidence generation, scientific engagement and communication as part of Launch Readiness activities and life cycle ... USOMA Plan. Provides medical review of expanded access programs (EAP) and, investigator-initiated studies (IIS) as part of a US IIS Review Committee, for assigned… more
- Merck & Co. (Rahway, NJ)
- …investigational or marketed Oncology drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as ... in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigation plans for delayed activities. Ensure that appropriate internal and external communication is current and clear. Ensure communication of the progress ... Experience planning and conducting Medical Affairs interventional and non-interventional studies , including Ph 3b/4, EAP, externally sponsored research, external… more
- Aequor (Providence, RI)
- …organization as a subject matter expert of clinical and commercial product stability studies and GMP data management. In this team-based role, you will directly add ... resolution and investigations. The Specialist Stability builds and monitors stability studies within quality systems (eg LIMS), owns and handles product quality… more
- Merck & Co. (South San Francisco, CA)
- …gene editing for precision cellular models to enable mechanism of action studies and analytical characterization of molecular concepts.Contribute to and lead the ... and clones to enable functional assays and mechanism of action studies .Experience working with disease-specific cell models and optimizing nucleic acid delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mitigation plans for delayed activities. Ensure that appropriate internal and external communication is current and clear.- Drive the development of Areas of ... Experience planning and conducting Medical Affairs interventional and non-interventional studies , including Ph 3b/4, EAP, externally sponsored research, external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other functional groups to ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… more
