- Merck & Co. (Rahway, NJ)
- …ideal candidate will be responsible for overseeing the development and maintenance of clinical databases and ensuring the integrity, consistency, and confidentiality ... operations.Key Responsibilities:- Lead Data Management Initiatives:-Direct the development and maintenance of comprehensive databases designed to collect and retain… more
- Merck & Co. (Rahway, NJ)
- …Core and Local Labeling documents.You will be responsible for the development and maintenance of Core and US Labeling for assigned products, ensuring compliance with ... internal and regulatory standards.You will assist in the development and maintenance of Local Labeling for EU and other regions.You will serve as a subject matter… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and other Portfolio Analytics. The role will be responsible for the development and maintenance of a Data Repository for Revenue and NPV models along with key ... Prioritization from Regional and Global Forecasting teams via the development and maintenance of a Database of Forecasts with the ability to produce Reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP SuccessFactors).Lead respective ... and collaborate with respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. This position ... drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meeting materials (PPT slides, meeting notes, training materials, etc.) Support maintenance and improvements to internal departmental website Develop reports to ... track key performance indicators (KPIs) and metrics Education/Experience: Proficient in ExcelStrong communication skillsExperience managing dataProject management and operational experience helpful Qualified candidates must currently be enrolled in an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the GCL, if applicableDelivers all relevant components needed for maintenance of product licenses (eg, Core Data Sheet generation/revision; clinical ... benefit-risk assessments for license renewals, responses to Health Authority)Participant and voting member in the labeling development process in the Labeling Working Team (LWT), in collaboration with the CDLContributes from a medical strategy standpoint to… more
- Merck & Co. (Rahway, NJ)
- …optimization, liquid chromatography separation, mass spectrometer operation and maintenance , data interpretation, and analysis.Extensive knowledge of Thermo, Sciex, ... Agilent and Waters instruments.Familiarity with Genedata or other biopharma MS software.Excellent verbal and written communications skills, as demonstrated through high impact scientific publications and presentations.- Preferred Experience and Skills… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Technology, our Research & Development Division Scientists, Maintenance , Automation, Plant Operations, and Safety), Engineering Firms, and ... Vendors to progress deliverables.The Associate Director is responsible for leading the planning, design, and implementation of engineering solutions on a suite team within a large capital project or leading capital projects less than $100MM in value. -Core… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with counterparts from (license) partner companies. Responsible for development and maintenance of a PVA repository Lead development of contract templates in ... cooperation with Legal Department and PV functions. Drive development of standards for information exchange with partners in cooperation with PV functions. Initiate the implementation of obligations deriving from these contracts. Organize and conduct periodic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Annual Reports: Responsible for the preparation, processing, filing and maintenance of all distribution and business license initial applications, and/or ... renewals. Responsible for tracking expiration dates and regulatory changes to ensure timely filing. Preparation of all applications and related documents and research for attorneys as to requirements, regulatory rules and state-specific changes so that final… more
- Merck & Co. (Rahway, NJ)
- …collaboratively with the IP Systems Administrator on the following:Database maintenance activities, including status checks and data validation, to minimize ... data discrepancies that would prevent accurate renewal paymentsEnsuring appropriate testing of law updates, system releases, and enhancements Assessing and designing new process workflows or data-related projects and improvementsAssessing and designing custom… more
- Merck & Co. (Rahway, NJ)
- …listings, figures) for early oncology studies.Responsible for design and maintenance of statistical datasets that support multiple stakeholder groups, including ... clinical development and safety evaluation.Collaborate with statistics and other project stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.Effective analysis and report programming development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all current business requirements in the following areas: vendor master maintenance , invoice processing, cash forecasting, payment processing, monthly and quarterly ... accrual preparation, including:- The day-to-day Accounts Payable and TE processes- Month end and quarterly disbursement closing processes- Vendor software administration for various ancillary applications- Support of the current staff on issues resolution-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements across studies related to a similar compound. Develops and oversees the maintenance of the study specific SAE Flow Plan and collaborates with on behalf ... of CSPV Operations any other study related documentation such as the DMP, SOWs, PVAs, Clinical Study Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents.Electronic Data Capture (EDC)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …plans, including training and support models, to ensure ongoing system maintenance and performance. Qualifications: Successful candidates will be able to meet ... the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree Bachelor's degree in computer science, information systems or related field required Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …organization to ensure smooth transition from system implementation to maintenance . Identify, assess, and mitigate technical, regulatory, and operational risks ... while ensuring these systems are inspection and audit ready. Overall accountability, ensuring higher quality project outcomes with optimal use of resources.- Provide such reports that are required to update both management and the business on the progress and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and ensure accurate and high-quality deliverables. Ensure documentation and consistent maintenance of code, logs and output within a regulated computing ... environment.Create and maintain specifications as per CDISC SDTMIG. Perform SAS programming to provide complex data review listings and reports to support Data Management and clinical teams. Develop, implement and maintain SAS programming standards and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages the review ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines, internal company procedures and company business objectives. This position manages new projects and… more
