- Merck & Co. (North Wales, PA)
- …development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional teams with sufficient influence ... & Development organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core...and mastery of project management to take on simple projects… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed… more
- Insmed Incorporated (Bridgewater, NJ)
- …and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the clinical ... study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines,… more
- Aequor (Thousand Oaks, CA)
- …as the top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills ... hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will...the ability to present themselves well.* 6&plus years of project management experience - Pharma familiar with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams ... for partnering with the Global Team leader as the Project Management lead on drug development projects....proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a… more
- Tris Pharma (Monmouth Junction, NJ)
- …the organization and by applying overall and specific project management and organizational leadership expertise to the clinical development portfolio. ... of issues for trial or program level deliverables to senior management , etc.); Develops, implements, and/or manages...and external contractors Provides oversight and support to CRO Clinical Operations and Project Management … more
- Merck & Co. (North Wales, PA)
- …and external stakeholders including Statistical Programming, Statistics, Regulatory, Data Management , Clinical and other project stakeholders.-Primary ... at a project level; ability to collaborate with key stakeholders.Solid project management skillsDemonstrated success in the assurance of deliverable quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at a project level, and interacts with regional and global project team members, senior management , and outside vendors.ResponsibilitiesResponsible for ... drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase... team members, and to a limited extent with senior management and outside vendorsMentors more junior… more
- Merck & Co. (Rahway, NJ)
- …work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation ... organizational skills to multi-task.Desire and willingness to learn, contribute and lead. Project Management experience with demonstrated skills.Candidate must be… more
- Eisai, Inc (NJ)
- …PCS, protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global study and project team members, and to a limited extent with senior management , and outside vendors; works independently for all phases of studies ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Merck & Co. (Rahway, NJ)
- …and experimental design.Strong scientific leadership in design and analysis of clinical trialsStrong project management skills. --Solid knowledge ... to effectively communicate results of clinical trials to the project team, our company's Management , regulatory agencies, or individual… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …components of a large-scale global clinical program using strong clinical project and program management , leadership, decision-making ability, ... of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Merck & Co. (Rahway, NJ)
- …relevant work experience.- Required Skills and Experience :Prior supervisory and project management experiences are necessary.Solid knowledge of statistical ... developing and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management , and… more
- Eisai, Inc (NJ)
- …Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ; ... Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The base salary… more
- Insmed Incorporated (Bridgewater, NJ)
- …nonclinical safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the ... teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the… more
- Merck & Co. (Rahway, NJ)
- …trial level. Primary activities include, but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager ... and business areas.Exceptional organizational, problem-solving and negotiating skills.Demonstrated excellent project management and leadership skills.#EligibleforERP MRLGCTO#ONEGDMSNOTICE FOR… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …communication between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early ... This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to...drug portfolio from the Research stage to post marketing/lifecycle management . Our expectation is that the person filling this… more
