- Merck & Co. (North Wales, PA)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... lead and influence others outside of a direct reporting relationshipBroad organizational awareness and knowledge of touch points/interdependenciesDemonstrated… more
- Insmed Incorporated (NJ)
- …and timely completion and hand-off to routine commercial manufacture.What You'll Do: Lead project teams for Technical Operations activities, both within Insmed ... the future of science, we're in. Are you?About the Role: Reporting to the Director of Technical Operations, Project...and with external contractors. Lead the transition of projects from Research into Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in Raritan, NJ. Role OverviewThis position will be responsible for providing project lead support for strategic initiatives and capacity expansion activities ... and priorities of the plant. This position will also be responsible for establishing and reporting on key project /program metrics in support of on time and on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and priorities of the plant. This position will also be responsible for establishing and reporting on key project /program metrics in support of on time and on ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager, Site PMO as part of the Technical Operations team based in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CAPA Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical ... centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director, Medical Affairs QA, the...leading global projects with high impact with ability to lead and project -manage cross-functionally and globally with… more
- Merck & Co. (Rahway, NJ)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership ... Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology) Reporting into the Director Packaging Distribution, Components and Systems… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition description:- Lead the statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development ... projects.Develop and execute statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timelines.Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. ... regulatory authorities. Provides compliance metrics to management, as needed. Lead continuous improvement around development of new signal workflow/process,… more
- Insmed Incorporated (NJ)
- …of release, stability, and in-process testing in accordance with cGMP, regulatory requirements, and company quality standards. The successful candidate will provide ... timely execution of testing activities. Core responsibilities include maintaining regulatory compliance, ensuring data integrity, and driving operational excellence… more
- Merck & Co. (Durham, NC)
- …and Validation.We are seeking a Maintenance Manager in Durham, North Carolina to lead a team of high performing Maintenance Technicians. The Manager will provide ... and technical guidance to maintenance technicians for a capital project startup. In this role you will actively manage...electrical maintenance and repair of electrical systems and equipmentActively lead the daily Tier 1 process and participate in… more
- Genscript USA Inc. (Piscataway, NJ)
- …site staff, contractors, and project teams. Support permit applications and regulatory reporting . Lead site inspections, audits, and emergency drills. ... federal regulations. The ideal candidate will have strong experience in construction project support, including providing EHS input during early design and planning… more
- Eisai, Inc (Houston, TX)
- …& Cross-functional Influence, Critical Thinking & Business Agility, Industry & Regulatory (Market Access), Mentoring/ People Development, Project Management, ... The ARM role will be a field-based individual contributor reporting into the Eisai Access and Reimbursement team under...Access and Reimbursement, the ARM, will be the functional lead for Access and Reimbursement activities across HCP offices,… more
- Repligen (Waltham, MA)
- …who will oversee the Company's accounting processes across all global subsidiaries. Reporting directly to the Chief Accounting Officer, this role has a high ... accounting). This person must also bring a demonstrated ability to lead , mentor, and inspire teams through organizational change while driving operational… more
- Eisai, Inc (Nutley, NJ)
- …days on site in Nutley, NJ (Tuesday Wednesday and Thursday). Key Responsibilities Lead the development and execution of the annual Ethics & Compliance monitoring ... of commercial call logs and HCP payment records Serve as the operational lead for Eisai US's Compliance Monitoring Program, managing internal resources and external… more
- Insmed Incorporated (NJ)
- …protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and interacts with cross-functional teams.What You'll ... Do: Lead complex clinical trials or indication corresponding to one...aspects of statistical design, study setup, execution, analysis and reporting of clinicals.Manage the timelines and oversee the quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Associate MES Engineer will be part of MSAT team reporting to the Manufacturing Execution Systems Lead and will be responsible for ... Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and… more
- Nevada System of Higher Education (Las Vegas, NV)
- …Internal Auditor serves as the second-in-command within NSHE's Internal Audit Department, reporting to the Chief Internal Auditor. This position partners with the ... and System Administration. The incumbent leads the planning, execution, and reporting of internal audit engagements, manages professional staff, and ensures… more
- SMBC (New York, NY)
- …support across the Advisory Function with respect to broker-dealer-applicable regulatory engagements, support function coordination, governance and reporting . ... Change Management + Compliance Alerts and other Communications Governance and Reporting : The Regulatory Governance Team is responsible for producing management… more
- Xcel Energy (Denver, CO)
- …looking for. **Position Summary** Serves as a subject matter expert and team lead for the company's Job Architecture implementation. This role will play a central ... developing job families, levels, and evaluation methodology. The position will lead the facilitation of job evaluations, establish governance practices, and partner… more
