- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio ... Oversight : Assess and oversee IT compliance responsibilities, providing risk assessments.Policy Development: Develop and implement policies, procedures, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the OEDC, supports the OEDC ... with an equally robust and agile infrastructure. The Program Lead plays a central role in supporting OEDC to...strategy and execution for DS. This position provides direct oversight of the internal OEDC staff necessary for meeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to exercise influence at ... GLP/non-GLP/ Research submissions to Health authorities globally. Provide QA oversight of GLP/GCLP activities of Daiichi Sankyo, contract research organization/… more
- Eisai, Inc (Nutley, NJ)
- …Security Engineer is responsible for building out the organizational capabilities to lead and manage Eisai's security engineering activities related to Identity & ... overall security objectives and industry best practices.2. Leadership and management: Lead a team of infrastructure technical security professionals across the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary / Objective Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Job Summary: Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support… more
- Merck & Co. (Rahway, NJ)
- …(Design Control per ISO 13485, QMSR, Part 4). Lead quality oversight of product validation, verification, and risk mitigation activities.Regulatory CMC ... requirements throughout the product design, development, and manufacturing processes.Implement risk management principles (ISO 14971) in design and development to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …clinical trials. Serves as a primary source of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the ... are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support… more
- Merck & Co. (Rahway, NJ)
- …plan. This role represents an excellent opportunity for a leader seeking to lead a team of talented scientists, provide oversight to multiple programs, ... within the Development Sciences and Clinical Supplies (DSCS) organization and lead a group of exceptionally talented scientists supporting externalized analytical… more
