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SAP Project Manager
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Groupsoft Us Inc Princeton, United States**Title: SAP Project Manager** · Company: GROUPSOFT · Location: Princeton, NJ · Employment Type: Full-time · Industry Domain: Retail · Area: SAP Software Consulting Services · Travel: _Based in Princeton · - Occasionally Travels to Client Site in Philadelphia_ · **COMPANY DESCRIP ...
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Project Manager Electrical
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Apex Innovations Princeton, United StatesResponsibilities: · Planning, preparation, and responsible execution of MEP projects, specifically in the electrical trade · Supervision and leadership of team members in project teams · Creation of construction and installation plans, technical calculations and designs · Point o ...
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Project management in the areas of inclusion
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Stellar Enterprises Princeton, United StatesWOULD YOU LIKE TO ACTIVELY PROMOTE INCLUSION IN OUR REGION AND SOCIETY? We are looking for a dedicated project manager to oversee projects funded by Aktion Mensch with passion and expertise in the areas of inclusion, event management, and public relations. PROJECT MANAGEMENT IN T ...
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Cascade Solutions Princeton, United StatesWhat can you expect? · You will be responsible for projects in turnkey construction up to 5 million euros · You will handle the clarification and implementation of technical and regulatory requirements · You will be in charge of tendering and awarding contracts for trades · You w ...
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ZephyrTech Princeton, NJ, United States Freelance**To strengthen our team at our location in Heidelberg, we are looking for a:** · **Part-time Production Preparation and Project Management Assistant (m/f/d)** · **Your responsibilities as a Production Preparation and Project Management Assistant (m/f/d):** · - Collecting and pre ...
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NebulaTech Princeton, United StatesWe are currently seeking a full-time (40 hours per week) employee (m/f/d) to join our team at our location in Sankt Augustin near Bonn as an entry-level project manager. As a company within the Sparkassen-Finanzgruppe, we have been providing secure jobs for over 20 years to appro ...
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Project Manager
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Stellar Innovations Mercer, United StatesThe MEDICLIN-IT GmbH is the IT service provider of the MEDICLIN Group. MEDICLIN operates 32 hospitals, six nursing facilities, and ten medical care centers throughout Germany. With almost 8,300 beds and approximately employees, MEDICLIN is a leading healthcare provider. Our team ...
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Project Manager
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SAP Project Manager
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Collectibles Project Manager
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eBay Trenton, United StatesAt eBay, we're more than a global ecommerce leader — we're changing the way the world shops and sells. Our platform empowers millions of buyers and sellers in more than 190 markets around the world. We're committed to pushing boundaries and leaving our mark as we reinvent the fut ...
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Project Manager
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RiseIT™ Solutions Princeton, United StatesPosition: Senior Project Manager(University Services) · Multiple Locations : Princeton NJ · Mode: Mostly Hybrid (4 days onsite and 1 days remote) · 24 months + contract · 36.25 hrs per week · Full Job Description: · Provide comprehensive project management support for two concur ...
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Project Manager
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Princeton Plasma Physics Laboratory Princeton, United StatesOverview: · PPPL invites applications for the position of NSTX-U Recovery Project Manager Electrical Mechanical Projects. · The NSTX-U Recovery Project is working to complete a major upgrade of PPPLs National Spherical Torus eXperiment (NSTX) fusion device located in Princeton, ...
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Project Manager
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SourcePro Search Princeton, United StatesSourcePro Search is conducting a search for an experienced Project Manager for our client in the securities trading system environment in Princeton, NJ. · This is a hybrid role (2 days in office / 3 days work from home) · The idea candidate will have a thorough understanding of ...
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AI Talent Flow Princeton, United StatesJob Description · Job Description · Transform your Agile career with AI TalentFlow. Are you ready to embark on a career journey that's dynamic, working with a rapidly growing company who will leverage your passion and energy for people and change management to propel themselves ...
Director Project Management - Princeton, NJ, United States - Genmab A/S
Description
The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at .At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussions
Ensures consistency of statistical methods and data handling across trials
Supports compound responsible programmer in developing an integrated database specification
Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles
Represent Genmab during meetings/congresses and courses and perform professional networking
Engage with regulatory authorities on trial level discussions
Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
Applying adequate methods for which a solid scientific foundation exists
Keep oversight and QC essential documents/data provided by vendors
Perform exploratory analysis, ad hoc analyses, and modelling of data
Perform UAT of Randomization part of the IRT system as applicable
Responsible for planning and conducting trial result meetings
Participate in definition, review, and approval of data packages for Data Monitoring Committees
Review and approve any amendments, corrections, and updates of data packages
Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
Support regulatory submission/filing activities
Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical area
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with the relevant regulatory requirements for biostatistics processes and SOPs
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Experience directing multiple complex projects/studies in a technical capacity
Proven performance in earlier role/comparable role
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
Follow scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussions
Ensures consistency of statistical methods and data handling across trials
Supports compound responsible programmer in developing an integrated database specification
Provide scientific advice to the CDT including design of trials, analyses and analyses requiring advanced statistical methodologies/techniques
Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or Partner meetings, as applicable
Ensure availability of integrated database(s), as needed, and planning and conduct of integrated analysis to support development decisions, submissions, and marketing needs
Support development and communication in relation to communication strategy and/or scientific input to presentations, posters, and articles
Represent Genmab during meetings/congresses and courses and perform professional networking
Engage with regulatory authorities on trial level discussions
Ensure biostatistician review of partner synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reports
Coordinate data transfers from/to business partners in collaboration with the programmer and the data manager, as applicable
Applying adequate methods for which a solid scientific foundation exists
Keep oversight and QC essential documents/data provided by vendors
Perform exploratory analysis, ad hoc analyses, and modelling of data
Perform UAT of Randomization part of the IRT system as applicable
Responsible for planning and conducting trial result meetings
Participate in definition, review, and approval of data packages for Data Monitoring Committees
Review and approve any amendments, corrections, and updates of data packages
Review scope of work (within own project) in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)
Support regulatory submission/filing activities
Master's or PhD in a statistical discipline with 12+ years of experience in relevant technical area
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with the relevant regulatory requirements for biostatistics processes and SOPs
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Experience directing multiple complex projects/studies in a technical capacity
Proven performance in earlier role/comparable role
You are a fierce believer in our rooted-in-science approach to problem-solving
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance.
Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success.
No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information.
Learn more about our commitments on our website .Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website .
Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.
For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies.
