- Aequor (Thousand Oaks, CA)
- …Strong analytical and Project Management ability with an eye for data quality Ability to develop and effectively present to executive level leadership Embody and ... in-depth analysis, coordination and negotiation with key decision makers Conduct project scoping and chartering, define implementation strategy, and guide 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 ... operational issues in a timely manner and continuous RPM process improvement with focus on quality , reliability, consistency and efficiency.ResponsibilitiesPlan,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure continued ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… more
- Merck & Co. (Durham, NC)
- …shop floor leadership.-Key Responsibilities for a Drug Product Operations Manager Accountability - Project SupportFirst-line operations supervisor with ... Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new...the design and construction of the facility, the Operations Manager will play a critical role in supporting the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the clinical study team are in accordance with DS standards. Act as the project manager of the clinical study team to liaise and coordinate with internal ... set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role,...lock.Ensure DS internal tracking systems are updated (eg Global Project Management System, GPMS). CRO and Quality … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic areas. Finally, this position has moderate skills in continuous improvement , project management, change management, and risk management. ... Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project /study team expectations regarding quality , time, and cost… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needs this position may take leadership and/or will participate in process improvement initiatives that are at the intersection of technology, process and analytics ... any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of… more
- Merck & Co. (Durham, NC)
- …the network of life-saving medicines and vaccines. - The Associate Director, Quality Systems and Compliance provides expertise in the coordination of resources and ... as applicable. Contributes to the performance and results of the expansion project . Adapts plans and priorities to address resource and operational challenges.… more
- Novo Nordisk Inc. (Durham, NC)
- …our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate ... developing & executing tactical & strategic plans. Relationships Senior Manager , Facilities, Utilities, Systems, Equipment (FUSE). Essential Functions Develop, coach… more
- Catalent (Harman, WV)
- The Manager , Supply Chain - Warehouse , reporting to the Director, Supply Chain, has an opportunity to make a significant impact on the way that the Harman's site ... operates. The Manager , Supply Chain - Warehouse will lead a shift...Materials Control Associates and Materials Services Associates. Responsibilities include: project participation, dashboarding, reporting, and governance. The scope includes… 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)
- …Unit operational activities for developing collaboration site, internal process improvement , developing business process and system integration. Contribute and ... Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and successful… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... produce safe, effective, innovative medicine.Primary responsibilities include:Operational planning and project management of epidemiology research studiesExecution, and close out… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to shape the future of Daiichi Sankyo clinical trials.Responsibilities- Process Improvement , Innovation and Optimization (IO):- Project manage GCO Strategic ... or biotechnology across clinical trial operations. Experience in training, process improvement , and project management required Experience Qualifications- 4 or… 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)
- …define and manage service-level agreements (SLAs), ensuring compliance and high- quality service delivery- Monitor vendor performance, conduct regular evaluations, ... vendor services- Identify and recommend cost-saving opportunities without compromising quality or attendee experience.Vendor Training - Design and deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process ... optimizing the defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory systems. This includes… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Disbursement team members and global colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ... Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …process for validated systems where necessary.Maintain effective communication with project stakeholders.- Provide oversight to assure that all validation work ... DX Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review… more
- Merck & Co. (Rahway, NJ)
- …this position include: Key Responsibilities PMO owner and steward of "Development Project Manager " user persona; accountable for defining business process user ... -management-centric activities.PMO owner and steward of PMO components of project management-centric training strategy, curriculum, content, and improvement … more
