- Eisai, Inc (Nutley, NJ)
- …products. Excellent communication and presentation skills, including experience with presenting to senior management and ability to explain complex concepts to a ... a difference. If this is your profile, we want to hear from you. The Director , Advanced and Omnichannel Analytics will be a member of the Business Intelligence team… 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)
- …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
- RIT Solutions, Inc. (Wayne, NJ)
- …controls, and overall governance of the production of regulatory reporting. Detailed tasks: Project Management Office: Organize and present the progress of the ... Title: Program Director of Regulatory Reporting - Must have current...project to the overarching Steering Committee, Setup and manage...advancement of the streams to the steering committee and senior management , lerts senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting ... development valuations in order to provide strategic guidance to senior management , support commercial and strategic decision...and ensure tax collaboration: work directly with the BD project lead as well as legal team to proactively… more
- Merck & Co. (Rahway, NJ)
- …present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsWilling to travelAble to ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… 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)
- …thinking to advance ADC, Complex Biologics and Small molecule portfolio. Project management skillsAttention to technical detailBuilds collaborations across ... and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… 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)
- …to communicate program progress, issues, and mitigation plans to the senior management .Innovative mind-set demonstrated by technical accomplishments, external ... Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred… 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)
- …Adherence to Schedule and Budget for Deliverables, Leadership of Teams, Vendor Management , And Demonstrated Communication With Senior LeadersAPI Small Molecule ... Job DescriptionDUTIES:Responsible for complex workstreams and implement capital project scope and technical studies that support business objectives, with focus on… more
- Merck & Co. (Rahway, NJ)
- …skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management , and/or medical field experience OR ... Master's Degree +3 year of pharmaceutical, clinical drug development, project management , and/or medical field experience OR PhD/PharmD Degree in life sciences,… 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)
- …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
- Teva Pharmaceuticals (Parsippany, NJ)
- …making a difference, and new people to make a difference with. The opportunity The Senior Director of Value & Access Strategy works closely with US Innovative ... interpersonal skills and the ability to communicate effectively Sound organizational skills Project management skills and focus on delivery of results Proven… 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
