• Daiichi Sankyo, Inc. (Bernards, NJ)
    …decision-making skills. Skilled at conflict resolution / negotiation.Strong project management skillsConsiderable organization awareness (eg, interrelationship ... other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high… more
    HireLifeScience (06/02/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... policies, regulatory requirements and ICH guidance. This position requires excellent project and people management skills, verbal/written skills, analytical,… more
    HireLifeScience (05/27/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...or related CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA… more
    HireLifeScience (05/15/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    … and Training functionsMust have proven people leadership experience.Must have demonstrated project management skills and experience working on global projects ... Overall accountability is develop strategic framework work for GxP document management and GxP training across DS group including business units, functional… more
    HireLifeScience (06/06/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …priorities.Will be expected to serve as the lead with the vendor & project management requirements for initiative completion.Will partner with the Director ... centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is...to serve as the lead with the vendor & project management requirements for initiative completion. Will… more
    HireLifeScience (05/08/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... and maintain the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient...Required Skills10 or more years of professional experience at senior management level leading quality organization and… more
    HireLifeScience (04/25/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates ... as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team...and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel:… more
    HireLifeScience (05/29/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, people … more
    HireLifeScience (03/28/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …risk management , and/or translational researchMust have excellent communication, project management , writing and analytic skillsMust be organizational leader ... CSPV HR-related matters, including performance reviews and departmental talent development.Line management and senior leadership accountabilities in CoELead a… more
    HireLifeScience (03/26/25)
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  • Daiichi Sankyo, Inc. (Bernards, NJ)
    …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
    HireLifeScience (05/13/25)
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