- 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
- 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
- Merck & Co. (Rahway, NJ)
- …and negotiate with key c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic understanding ... regulatory, clinical & pharmacovigilance processes- Demonstrated ability to collaborate with senior management and information workers on the importance and… 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
- 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
- Merck & Co. (Rahway, NJ)
- …requirements and convert them into actionable solutions and process specificationsStrong project management skills and ability to conduct complex reporting ... Audit, Legal Regulatory Compliance, Metrics Analysis, Problem Solving, Process Improvements, Project Management , Project Risk Assessments, Regulatory Affairs… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at ... of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse backgrounds.-… 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
- 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
- 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
- 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
- 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
- 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
- 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
