- BioAgilytix (Durham, NC)
- …connecting our internal functions to the actions required of an efficient and quality -driven project process. You'll experience a broad range of responsibilities ... to detailAbility to coordinate multiple projects/tasks while still delivering high quality results under time constraintsStrong organizational and project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination. This position collaborates within global CSPV and cross-functional teams. As a project manager this position is responsible for working with the ... rare diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the Project … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides ... planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... lead a team of API Optimization Specialists, Manufacturing Area Specialists, and Project Managers in the execution of the manufacturing suite robustness and capacity… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project . ... manage sub-teams of more complex projects in collaboration with a more senior project manager . Establishes and maintains a high performing team.Partners with the… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our ... control and deviation processes at NN Boulder, specifically in the role of Quality Assurance (QA) subject matter expert (SME).This position is also responsible for… more
- Merck & Co. (Durham, NC)
- …site subject matter expert in rollout and implementation of Durham's new project management software platform, OnePMO.Participate in GVO OnePMO Community of Practice ... to site personnel.Support, maintenance, and governance of the Durham capital project portfolio, including all active and future projects.Provide portfolio updates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project /study team expectations regarding quality , time, and cost ... assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. Develop and maintain positive rapport and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external ... stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure its quality and integrity- Oversee statistical programming vendor on project planning and execution to ensure high quality deliverables and timelines ... and Table, Listing, and Figures (TLFs) generated by vendor, ensure deliverable quality , and expedite the preparation of oncology compound regulatory submission. It… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... As the Lead Medical Writer, the 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)
- …Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful ... Maintaining vendor contracts, contractor data, and critical database information.Responsibilities- Project Management- Plan and execute various projects within the… more
- Merck & Co. (Durham, NC)
- …several years; currently Durham employs 1,000+ people. This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... a team of individual contributor production direct reports including safety, quality , and daily operations;Ensure that Shift(s) objectives are achieved while… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.Senior Manager , US Alzheimer's Strategy and Lifecycle Planning Marketing will assist with the ... business partners and external agenciesPotentially Lead or Co-lead cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics… more
- Merck & Co. (Rahway, NJ)
- …Lead (CQOL) and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for the execution of operational ... new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Aequor (NJ)
- 100 % remote Manager prefers local candidates (will consider non local candidates as well) Required bachelor's degree Must Haves: Phase 1 to 4 clinical trial ... during phases 1-4. The individual must partner closely with clinical, regulatory, quality and production associates to ensure timely delivery of supplies to study… more
