- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical sections of submission documents under guidance of CSL and/or Medical Monitor . Represents Clinical Development on Study Team and collaborates as team member ... This position provides critical support to the CSL and Medical Monitor in the execution of Clinical Development functions. Responsibilities: Study Strategy:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with relevant teams to streamline case management processes and enhance efficiency. Lead Case Management and Medical Review Direct the management of safety cases, ... submission queries. Focus on Post-Marketing Adverse Events Develop strategies to monitor and manage post-marketing adverse events. Ensure effective communication of… more
- Merck & Co. (Durham, NC)
- …at the Vaccine Manufacturing facility in Durham NC, the Planning and Scheduling Lead will be responsible for the overall planning and purchasing processes in support ... (BCG Teknika), Tice (BCG Hilleman) and Vaccine Bulk Facility (GBF).- The Planning Lead is part of the Sitewide Leadership Team (SWLT) and interacts frequently with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies as well as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create ... initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.Validate the… more
- Aequor (Houston, TX)
- …Management: Liaise with the inventory team at the internal warehouse to monitor on site inventory (quantity and accuracy) Forecasting and Planning: Work closely ... of materials. Any delays or mismanagement of inventory can lead to production stoppages, causing significant delays and potential...in data analysis and the use of reporting tools to manage and monitor inventory data, KPIs, and replenishment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …employer including veterans and people with disabilities.SummaryThrough strategic leadership, lead and manage skills and capabilities development initiatives for the ... through established interactions with Japan and Europe as required.Responsibilities- Lead the Global Finance and Procurement Capability Building Program- Design… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …leading different investigations work-cells, drive investigations to closure, support escalations, monitor and improve performance metrics for team. They will also ... to implement new innovative manufacturing technologies.Key Responsibilities Individual will lead a team to support manufacturing investigations, capacity planning,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and new product commercialization assets (3 years prior to launch). They will lead the development and implementation of brand plans, development of capabilities to ... functions that drive success. They will be empowered to make strategic decisions and lead the development and roll-out of tactics that pull through the strategy and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance ... strategy in close alignment with the MA (Oncology and Specialty) business strategy. Monitor and track implementation and break-down of the Quality Manual into an… more
- Repligen (Waltham, MA)
- OverviewWe are seeking a strategic and experienced HR leader to establish and lead our North America Employee Relations Center of Excellence (ER COE). This role will ... as a subject matter expert and trusted advisor on employee relations matters. Lead complex employee relations investigations. Partner with key stakeholders to ensure… more
- Merck & Co. (Ames, IA)
- …and IT Business partners to drive continuous value through the solution.You lead business readiness and execution of defined deployment plans to ensure resource ... alignment, communicate status, and escalate issues. You don't hesitate to lead projects yourself and to role model flawless execution of projects. Change management… more
- Repligen (Waltham, MA)
- …the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders ... an effective internal control framework that spans all global operations. Lead the SOX compliance program, including risk assessments, documentation, testing,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …LRP) to evaluate manufacturing plans to ensure inventory coverage and supply readiness. Monitor supplier execution and deliverables of goods and services aligned with ... scope of work. Monitor product life cycles and alert appropriate team members...disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …We are looking for a dedicated and action-oriented Employee Engagement Manager to lead our engagement initiatives. In this newly created role, you will be ... report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee engagement program to cultivate a vibrant culture that… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ICS (Industrial Control Systems) is responsible for acting as a technical lead and trusted advisor, ensuring high availability, optimal performance, and reliable ... Facilitate effective communication and collaboration among all parties involved Define, monitor , and analyze key performance indicators (KPIs) and usage metrics for… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionThe Sr. Director, GMP Quality Assurance will lead the GMP QA strategy and execution for Formation Bio's portfolio. Acting ... development and maintenance of Quality Agreements with external partners. Monitor CDMO and vendor performance and ensure timely resolution...of QA. Assure the execution of QA Audit Plans, Lead internal and external audits to assess compliance with… more
- Novo Nordisk Inc. (Boulder, CO)
- …etc.) and acts as a key SME in the area to support and lead process improvements. Relationships This position will report to the Senior Manager, Materials ... shipment related communication to key internal and external stakeholders Initiate, monitor , and complete shipments associated with research material, raw materials,… more
- Novo Nordisk Inc. (Durham, NC)
- …personnel in accordance with the Novo Nordisk way. The Work Cell Leader / Team Lead will ensure the safe & effective operation of one or more work cells, while ... environment Setup next team for success Coordinate maintenance activities Lead team in Event Response/RCA Schedule work cell resources,...issues & escalate to manager as may be necessary Monitor performance & completion of training to ensure the… more
- Formation Bio (New York, NY)
- …the consistent production of safe, effective, and high-quality pharmaceutical products. Lead internal and external audits to assess compliance with regulatory ... implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement. In collaboration with… more
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