- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of ... to ensure compliance, contract fulfillment, and service excellence.Oversee global project budgets to ensure cost-effective solutions that meet compliance and… more
- Merck & Co. (Rahway, NJ)
- …of clinical pharmacology components of regulatory filings. Preferred Skills and Experience: -Solid project management skills and the ability to partner with ... Analysis, Data Management , Data Science, Drug Development, Numerical Analysis, Project Management , Project Support, Regulatory Submissions, SAS Language,… more
