- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a large-scale global clinical program using strong clinical project and programmanagement, leadership, decision-making ability, people management, and ... develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to Daiichi Sankyo's mission by leading conversations across functional teams (ie Grant Review Committees) around the grant and/or project decisions that meet the ... Internal Strategy and Operations- In alignment with senior colleagues, collect, review , and make decisions in collaboration with relevant Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- Merck & Co. (Rahway, NJ)
- …laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures.This position is based at the Rahway, New Jersey ... associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and… more
- Merck & Co. (Rahway, NJ)
- …data review , and author analytical reports and data summaries.Conduct project management and/or scientific oversight of studies and samples performed at Contract ... laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This position is based at the Rahway, New… more
- Merck & Co. (Rahway, NJ)
- …activities performed by external partners.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, ... milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Process for the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs ... QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs).… more
- Genscript USA Inc. (Piscataway, NJ)
- …performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight ... lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals… more
- Merck & Co. (Rahway, NJ)
- …party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed ... team accountable to deliver on priorities.Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing reports,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including project -specific training and coaching of team members and review of team output cross-functionally.Effectively represent the CSPV on the Global ... Safety MD, will lead the development and implementation of integrated project /product risk management strategies aimed at achieving the optimum benefit-risk for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in setting strategies and plans for their teams with the CROs. Responsible to review metrics and issues for their studies and ensure proper attention and mitigations ... the needs of the overall development plan agreed to by the Global Project Team (GPT). People and Resource Management:Develops talent through providing focused career… more
- Merck & Co. (Rahway, NJ)
- …into GSVC Annual Product Plans. This includes leading the development, review and communication of GSVC individual content within the V&I ... Enterprise Leadership Responsibilities:Leads projects and solves complex problems: Oversees project management, providing solutions to complex issues, and guides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership, ... level.- Provides the highest level of CRO/vendor oversight to ensure project plans are executed properly (eg, operational leadership teams). Functional Expertise:… more
- Merck & Co. (Rahway, NJ)
- …to headquarters submission (ex-USA) and in collaboration with RDMAs, while also serving as a review panel member on TA specific MISP's to support the EDSA review ... analytical, communication skills (written and oral) in addition to results-oriented project management skillsPreferred: At least 3 years regional medical affairs… more
- Merck & Co. (Rahway, NJ)
- …CAPA & Deviation management to ensure timely closure of any observationsAuthor, review , and approve GMP procedures and documentation, with an emphasis on operation's ... Validation, Operational Excellence, Personal Initiative, Process Optimization, Product Testing, Project Team Leadership, Quality Management, Quality Management System Auditing,… more
- Merck & Co. (Rahway, NJ)
- …to ensure timely execution of outsourced GMP testing.Perform data review of laboratory notebooks and analytical reports.Author release specifications, analytical ... associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy ... Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the appropriate section of… more
- Eisai, Inc (Nutley, NJ)
- …provide sound input on Clinical Pharmacology activities to a variety of project teams. Essential Functions Directs and Implements clinical pharmacology plans and ... interpretation of clinical data.Serves as Medical Monitor (where applicable) to review and monitor study data.Implements strategies to identify, monitor and resolve… more
- Tutor Perini (Newark, NJ)
- …now or in the future Tutor Perini O&G, a JV, is seeking a ** Project Engineer-Steel** to join our **Newark AirTrain** project team at **Newark International ... need Exceptional Talent_** **Job Summary:** We are seeking a highly skilled Project Engineer with expertise in steel structures to join our civil construction… more
