- Aequor (Devers, TX)
- … Migration Support: Support and lead all discussions on data migration and ensuring data compliance from one ERP System to the other. Data Testing: Act ... Lead is located in Devens, Massachusetts. This role will report to the Devens Associate Director, Cell Therapy Site...etc. Vendor Setup: Manage vendor setup from one ERP System to another ERP Systems (ie, Oracle… more
- Merck & Co. (Rahway, NJ)
- …This role requires excellent analytical, negotiation and communication skills.This role will report directly to the Chief of Staff to the General Counsel & ... leading RFP projects, managing timelines, preparing reports and analyzing data , creating presentations, and coordinating deliverables. Respond to inquiries from… more
- Repligen (Waltham, MA)
- …Supplier Quality.Responsibilities Supplier Performance Monitoring and ReportingCollect, analyze, and report on monthly supplier performance data , including ... quality, delivery, and service metrics.Prepare and distribute supplier report cards in a standardized format to internal stakeholders and suppliers.Maintain and… more
- Merck & Co. (Boston, MA)
- …Familiarity with GenAI is a plus.-In addition, the candidate will leverage data to drive resource utilization and maintain up-to-date awareness of literature-related ... requests with Library team membersManaging access to external information systems such as databases, literature platforms, and pharmacopoeiasCollecting and reporting… more
- Aequor (Houston, TX)
- …and containment of the event, address comments from stakeholders on the compiled final report o Displays ability to gather data from various sources across the ... to moderate scientific events into a brief and cohesive report as a finished product o Demonstrates ability to...of the deviation investigation o Familiarity with cGMP quality systems , and demonstrates ability to read and comprehend GMP… more
- Merck & Co. (North Wales, PA)
- …and validate as required, study designs, protocols, measurement questionnaires, case report forms, data analysis plans, and final reports/publications.Works with ... the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based...as outlined in the OR planning process and generates data on a worldwide basis to support pricing and… more
- Aequor (Houston, TX)
- …event, address comments from both internal and external clients on the compiled final report . Gathering Data from various sources across the site, performance of ... translate difficult and complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability ... and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice...carry out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for… more
- Merck & Co. (Rahway, NJ)
- …clinical and commercial assembly equipment and processes for medical devices/drug delivery systems . Reporting to the Director responsible for this area, you will ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Novo Nordisk Inc. (Tyler, TX)
- …and other paramedical customers and current co-promotion partners. Internally, the DCS I report to the District Business Manager of the specific sales territory. The ... of territory customer groups and affiliations such as IPAs, Medical Groups, Health Systems , and Local Clinics and uses this to identify business opportunities and… more
- Eisai, Inc (Nutley, NJ)
- …strategy for global MA/MSL training that is personalized, integrated with Eisai systems , and data -driven.Support new hire MSLs scientific training via didactic ... medical affairs personnel to enter strategic and compliant discussions regarding medical/clinical data on Eisai products. The AD assumes a leadership role by… more
- Merck & Co. (Rahway, NJ)
- …partners, designs studies, authors study protocols, develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific ... needs of clinicians, payers, policymakers, HTA/reimbursement agencies, and health systems globally.Types of studies executed include prospective and retrospective… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database ... through the entire product lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and… more
- Eisai, Inc (Louisville, KY)
- …with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers (healthcare pr ... exchanges and interactions with identified KOLs.Present clinical, scientific and economic data on Eisai's products and relevant therapeutic areas to population-based… more
- Merck & Co. (North Wales, PA)
- …designs studies; authors study protocols; and develops measurement questionnaires, case report forms, data analysis plans, final study reports, scientific ... payers, policymakers, health technology assessment (HTA)/reimbursement agencies and health systems globally.Types of studies executed include prospective and retrospective… more
- Genmab (NJ)
- …for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab ... deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, Policy and Intelligence. The position may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... DEP management and external task forces, as needed Reviews and audits direct report expense reports; manages and reviews time and activities (as collected and… more
- Merck & Co. (North Wales, PA)
- …Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise ... the entire product lifecycle. - Primary Activities : Effective analysis and report programming development and validation utilizing global and TA standards and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …include verification protocol execution (FAT, SAT, DQ, Commissioning, IQ, OQ, & PQ), data analysis and final report preparation Participate in the development ... well as the continued operation of such facilities Ensures systems and processes are verified and validated in a...with change control activities Ensures change control activities for systems are completed in a manner in compliance with… more
- Repligen (Clifton Park, NY)
- …key role in delivering the site expansion programs, implementing quality management systems and maintaining ISO certification. The individual will play a leadership ... Management Responsible for ensuring that work area is clean and safe Report metrics, as required.QualificationsBS degree in Engineering, Science or a related field… more