- Legend Biotech USA, Inc. (Raritan, NJ)
- …Successfully support the implementation, execution, and improvement of the internal audit process. Support the planning and execution of internal audits for ... all quality system areas for the manufacturing site; write audit reports, issue audit observations and follow-through to ensure satisfactory resolution and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technologies.ResponsibilitiesManages all payroll supporting processes and controls which include:Provides audit support for internal and external auditors. ... 401K (5500) audit and ensure all deadlines are met. Regularly leads audit support activities for Federal and State audits as well as Internal and Tax… more
- Merck & Co. (Durham, NC)
- …strong understand of Labware LIMS, handle Quality Notification authoring and provide audit support . GENERAL PROFILE: Collaborate with internal customers and ... products, continuing process improvements, troubleshooting, writing SOPs, and investigational testing support . The selected candidate will support the sterility… more
- Merck & Co. (Durham, NC)
- …Management System (LIMS), handle Quality Notification authoring and provide audit support .Primary Responsibilities: The emphasis is on microbiological ... bulk vaccine, filled vaccine, and media. The successful candidate will support the microbiology testing laboratories with emphasis on microbiological methods such… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …workflow automation that allows workload to be evenly distributed amongst all analysts. Audit support : Ensure Good Documentation Practices and lab readiness are ... upheld for potential support of regulatory agency audits.Downtime tasks: Includes the following...communication skill are required.Off-hour responses may be required to support business needs.Candidates must be able to accommodate unplanned… more
- Twist BioScience (South San Francisco, CA)
- …ERP system (SAP) and other finance related data sources. Maintaining and providing audit support as requested by internal and external auditors.Special projects ... This is a hands-on position that will be responsible for the IT support of accounting and finance needs, specifically dealing with all automation matters and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …point of contact with external auditors including preparation and review of audit schedules and support . Prepares and reviews monthly account reconciliations. ... Assists in preparation and filing of tax returns as needed. Perform all other related duties and tasks as required or assigned.Will identify staffing needs and available expertise, provide leadership and mentoring to all department staff and work with Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …major study commitments including resolving any key issues identified.Participate in or support internal audit and regulatory inspection activities related to ... CRA Monitoring Oversight and Excellence is responsible for the support of the strategic development, oversight, and execution of...across the DS portfolio. This position will serve to support the project plan of CRA Monitoring Oversight and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Organize and conduct periodic review of contract quality and adherence. Support business functions in determining PV relevance for vendor contracts. Ensures ... Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical… more
- Aequor (Thousand Oaks, CA)
- …the enterprise (R&D, Operations, and GCO). In this vital role you will support the quality management system team to provide proactive compliance oversight to ... Quality Management System organization. Under general supervision, provide tactical support activities to Quality Management System Lead. Specific responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality ... organization is in a perpetual state of compliance as follows: Support the Global Quality Lead(s) (GQLs) and Regional Quality...ongoing review of risks by evaluating Quality Events (QEs), audit , and inspection outcomes so these data may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready? The Position Responsible for providing consistent, high quality project support , reporting, and budget management in support of the US Talent ... Acquisition function. Responsible for coordinating and running projects in the support of US Talent Acquisition function. Relationships Reports to a manager in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to HCP engagement technologies, including service fees, licensing costs, and outsourced FTE. Support budget coordination and tracking, review and audit all final ... the accuracy and timeliness of HCP engagement records. The associate will support efforts to adapt and optimize systems, implement new technologies, and drive… more
- Aequor (Thousand Oaks, CA)
- …identify needs, streamline processes, and meet deliverables. This role will help support and understand current operations, redefine processes, and lead into a ... model. This position is a hybrid role and will require candidate to support in-person trainings and meetings at headquarters in Thousand Oaks, CA. Responsibilities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …costs.Ensure study budget is reconciled with Finance on an ongoing basis. Support all inspection readiness and quality initiatives pertaining to assigned ... Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.Conduct and/or oversee the CRO oversight...the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at US affiliates to accomplish the company's ESG goals and 2) support various components of the company's corporate sustainability programs, including external ... disclosure reporting and ESG auditing.Responsibilities- Manage and Support US Environmental, Social, Governance (ESG) Sustainability Initiatives and greenhouse gas… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …on the review of individual batch records, supporting test records and other ancillary support records. Will assist in the internal audit program and be a ... potential? The Position This position will review manufacturing and support documentation and records to certify compliance with in-house specifications/standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Summary Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, ... transformation plan to business, ensuring continuous improvement and optimal solutions that support business processes as well as unmet business needs.- Work with… more
- Genmab (Plainsboro, NJ)
- …resource allocation and ensure effective team planning.Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply regulations.Represent ... clinical trial drug supply.Maintain agreements, contracts, and SOPs to support efficient operations.Forecast demand, manage inventory, and prevent stockouts.Lead… more
- Genmab (Plainsboro, NJ)
- …participate in cross functional teams (CDTs, CSTs, CTTs, CMC) and support strategic cross functional collaboration (ie, project/program and trialsLead/Participate in ... all drug supply planning tasks, activities, and deliverablesGlobal Clinical Drug Supply: Support development and maintenance of SOPs for the Global Clinical Drug… more
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