- Legend Biotech USA, Inc. (Raritan, NJ)
- …Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation investigations management system. Ensure alignment ... in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management ...will provide strategic direction and leadership for the investigations management system. Working closely with the Quality … more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible ... development and implementation of global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management , is accountable for ... builds and maintains positive relationships with internal/external stakeholders/vendors/partners. - Project Management : Is accountable for quality of delivery in… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under… more
- Merck & Co. (Millsboro, DE)
- …of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ Director ... Millsboro Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Eisai, Inc (Nutley, NJ)
- …want to hear from you.JOB SUMMARY:As a member of the Data Analytics group, the Associate Director , Commercial Analytics is part of a high performing team that ... standards for the department, and monitors compliance with these standards.Oversee data quality management process for assigned brand/s with external and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategy & Investigations Owner/Lead as part of the ... an expanding global manufacturing network for best-in-class CAR-T product. Management oversight and/or contribute to strategic capacity plans/COGs reduction/TAT/OOS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a collaborative work culture, including direct partnership with the Operations Director (s) Stakeholder management : Build strong internal and external ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop, design, and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....organization to understand existing and future training and knowledge management needs Proven track record of developing training and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , People Analytics will execute and drive the strategic ... Strategic Leadership Stakeholder Engagement:In collaboration and partnership with the Director , HR Systems People Analytics, this role will drive the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guidelines, Policies, SOPs, and other relevant guidelines.Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality ... by partnering with internal and external stakeholders to optimize Data Management technology, processes, and standards (improving quality /inspection readiness,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions to meet smooth ... transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... of trial, clinical trial plan and contingency planning; Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... drug products consistent with the company goals; specifically, for the life-cycle management of NDAs/BLAs. This individual will be responsible for working on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager/ Associate Director , External Manufacture as part of the Global Manufacturing ... of the production plan at the CMO's. Leads the management review process with CMO's based on agreed KPI's...overseeing capacity expansion, monitoring budget, driving cost reduction and quality improvement and serve as Person in Plant. Serve… more
- Catalent (Harman, WV)
- …management and continually enhances self-sustaining processes that drive associate involvement and support decision-making at the lowest possible level.Supervises ... Senior Director , Supply Chain Position Summary: The Senior ... Supply Chain directs all facets of supply chain management including, but not limited to, purchasing, sourcing, logistics,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …administration of validated electronic systems such as LMS or other quality management systems.- Must possess strong interpersonal, communication, negotiation ... for Global RD/PV/MA QA relevant activities including QQR, monthly quality report, team building and management review.-...QQR, monthly quality report, team building and management review.- Involve and attend the Global QA relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment. Strategizes and plans for FDA meetings as needed. Acts as ... Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes Processes and Best Practices: Reinforces labeling best… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR...reports, value dossiers, and publications building on the high quality and scientific rigor of these deliverables. Represents HEOR… more
