- Daiichi Sankyo, Inc. (Bernards, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member ... with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key ... the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology...For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other functional groups to ensure budgets are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team ) for the ... and is accountable for the development and control of Clinical Project Budget in support of Phase I-III ...with organizational strategies and objectives.- People Leadership - May lead small team ; Coach, motivate and develop… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical ... This position is accountable for partnering with the Global Team leader as the Project Management lead ...and to drive the development and delivery of the clinical development plan in alignment with the product development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with CROs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review of the submissions. Provides guidance to peers and cross-functional team members regarding strategic regulatory issues. Develops timeline and strategic input ... Responsible for representing GRA in the GPT (Global Project Team ) as well representing the project team ...governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead , Oncology Global Clinical Development, ... the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical...as well as the ability to function in a team environment, are essential.- Preferred Experience and Skills: Board… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Clinical Research Director (CRD) is the Clinical Operations lead in a country/cluster and is responsible-for execution of all Clinical ... incumbent ensures a single point of contact for managing clinical trial execution in all its-aspects across phases in...for initiatives at all levels of the organization.Build and lead the team to effectively manage resources… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWithin the Development Sciences and Clinical Supply (DSCS) organization, the Digital Program Manager will advance the purpose and aspiration of our ... provide strategic and tactical direction and partner with the DSCS Digital Leadership Team to drive the Digital Strategy for our organization, comprising of Process… more
- Merck & Co. (Rahway, NJ)
- …, create future state, and deliver resultsResults-orientated with the proven ability to lead a team in execution of strategyCurrent Employees apply HERE Current ... Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research &...Division , is accountable for managing the 'end-to-end' integrated clinical supply chain across all of the R&D portfolio… more
- Merck & Co. (Rahway, NJ)
- …, create future state, and deliver resultsResults-orientated with the proven ability to lead a team in execution of strategyCurrent Employees apply HERE Current ... Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research &...Division , is accountable for managing the 'end-to-end' integrated clinical supply chain across all of the R&D portfolio… more
- Merck & Co. (Rahway, NJ)
- … Clinical Supply Planning organization to customers both internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply ... limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative)...clinical supply planning and incorporate them into the team 's operations. - Focus on Customers & Patients. -… more
