- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... reduce timelines, and support decision-making in biologics development and manufacturing. Project Management Own CMC timelines, budgets, and resources across… more
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Senior Director Commercial Innovation drives commercial innovation with a specific focus on ... prioritization, and budgeting Proven ability to work with and influence senior management Ability to synthesize complex information into user-friendly,… 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
- 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
- Merck & Co. (Rahway, NJ)
- … and communications plans to support adoption of business capabilities and toolsStrong project management skills and proven ability to manage multiple tasks at ... Alignment, Organizational Change Management , Organizational Changes, Personal Initiative, Project Management , Readiness Assessments, Risk Management ,… more
- Merck & Co. (Rahway, NJ)
- …related discipline required , MS/MBA preferred . - At least 8 years of experience in project management . - - At least 5 years of experience in planning, ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management , external vendors, and clinical sites. Strong… 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)
- … 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
- 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
- Merck & Co. (Rahway, NJ)
- …least three (3) years in direct management of shop floor production activities. Project Management - Proficient with Project Management and Virtual ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …think creatively to solve Outstanding team- and client-facing communication skills Project management skills Quantitative analysis skills Statistical programming ... you ready to experiment with us? The Position The Senior Manager - Market Access Insights works with the... Manager - Market Access Insights works with the Director - Market Access Insights to explore key market… 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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for efficiencies across the Novo Nordisk portfolio. Relationships Reports to the Director , NovoCare Platform and Services. Key internal relationships include IT, all ... optimized manner Develops and presents compelling plans and recommendations for management endorsement Function as subject matter expert on digital patient access… more
- Merck & Co. (Rahway, NJ)
- …influencing, coaching, and mentoring resources across various projects.Develop and implement project management strategies that align with organizational goals ... and strategic leader to join our team as a Director of Program Management and Execution Excellence....a culture of continuous improvement and innovation within the project management team.Ensure project costs… more
- Merck & Co. (Rahway, NJ)
- …like SAP GTS or Integration Point, or similar databases, very desirableStrong project management skills and ability to conduct complex reporting ... Investigative Skills, IS Audit, Legal Regulatory Compliance, Metrics Analysis, Process Improvements, Project Management , Project Management Information… more
