- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary:The Associate Director , Global Alzheimer's Disease Project Management is responsible for ... project schedule, timeline, budget and resource utilization to senior management on a regular basis. Leverage...Salary Transparency Language:The base salary range for the Associate Director , Global Alzheimer's Project Management … more
- Eisai, Inc (Nutley, NJ)
- …years of relevant programming and application development experience, 5 or more years project management & people management experience Experienced in ... user support to other areas of Data Operations, Data Management , Clinical Safety Data Review and Clinical team. The...programming and JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior … more
- Eisai, Inc (Nutley, NJ)
- …and comfortable presenting to all levels of an organization including its Senior Management . Strong personal and interpersonal skills, including the ability ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for...May serve as the lead regulatory representative on the project team throughout the product lifecycle. Provide senior… more
- 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
- Merck & Co. (Rahway, NJ)
- …excellence across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional ... excellence across inline program support projects, working collaboratively with the Senior Director , Directors, Associate Directors, and cross-functional teams.-… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... GCD, and Research and Development objectives.Leads strategic development and management of institutional & investigator relationships in conjunction with Research… 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
- 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
- Merck & Co. (Rahway, NJ)
- …in both strategy development and tactical executionDemonstrated excellence in Project Management .Experience in organizational change management ... Process, Occupational Health and Safety Management , Occupational Hygiene, Oral Communications, Project Management , Project Management Improvement, … more
- Merck & Co. (Rahway, NJ)
- …of our pipeline and make informed decisions to manage their parts of the R&D division. Senior Specialist, R&D Pipeline Project Management Office is a role ... leaders through organizational alignment and integrated planning and execution. The Project Management Office (PMO) within GPAM enables pipeline progression… 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)
- …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)
- … 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …- Strong analytical skills and experience and be results-oriented. Project and Change Management - Strong project management skills and a proven ability ... to lead and collaborate with a wide variety of individuals, including senior management , stakeholders, team members, other departments and suppliersProven… more
