- Aequor (Thousand Oaks, CA)
- …degree and a minimum of 2 years of hands-on experience in document management , including workflow coordination and system administration. Proficiency with ... Viva or comparable document management platforms is required. Strong background in project management and technical writing is essential. The Controlled… more
- Merck & Co. (North Wales, PA)
- …project progression, coaching on Company processes relating to CMC development team management , strategic document preparation, PM skills, and Team Management ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the Research & Development...health and business.- -Under GPAM, the CMC Integrated Project Management (CIPM) organization supports Development and Commercialization Teams (DCTs)… more
- Genmab (NJ)
- …MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for ... communicate risks, and recommend course of actionSelf-starter with superior time management skills, ability to balance multiple tasks to meet priorities and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV stakeholders ... for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received from CSPV vendors.Responsibilities:… more
- Merck & Co. (Rahway, NJ)
- …enable digitization . - Experience in digitization and data management initiatives in regulated environments, including source- document ... Analyst, will o ptimize regulatory authoring processes and enhance data management by mapping workflows, prioritizing source documents for digitization, and… more
- Aequor (Thousand Oaks, CA)
- …onsite if systems go down and manual processes required. Experience with Quality Management Tracking Systems (QMTS) is preferred but not required - full training ... Service Providers - Partner with clinical site staff and Quality to document , investigate, and communicate decisions concerning distribution complaints. Sales Order … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …head.Provide timeline to address issues and verify that issues were corrected and document the results in the audit check list.Provide, Manager, Manager of Meetings ... all approvals have been received and captured in DSI's HCP Engagement platform. Appropriately document and address any discrepancy of the FMV rate in the MCA & RFS… more
- Repligen (Clifton Park, NY)
- …ensure a motivated and effective team environment Provide training in document -controlled manufacturing techniques. Approve shift schedules and vacation requests to ... standards that are carried out in accordance with Repligen's Quality Management System Monitor production processes, troubleshoot issues, recommend improvements and… more
- Twist BioScience (South San Francisco, CA)
- …and in alignment with business needs and strategic objectives.Gather and document detailed business requirements for projects, ensuring clarity and alignment across ... of experience in a related field5+ years of experience in digital product management in a scientific or biotech environmentExperience as a business system analyst in… more
- Merck & Co. (Rahway, NJ)
- …and traceability.Familiarity with source systems such as LIMS, Veeva, and document formats like PDF, enabling effective data extraction, validation, and ... to detail and accuracy in data handling.Understanding of master data management and manufacturing ontologies to support consistent data definitions, relationships,… more
- Formation Bio (New York, NY)
- …to align semantic models with real-world use cases. Enablement & Documentation: Document data standards and reusable modeling patterns to empower downstream teams ... considerations in healthcare, pharma, or finance. Practical use of metadata management and data catalog platforms. Hands-on experience structuring dbt projects with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Support medical readiness activities for market launches and life cycle management for select indications/projects. Gains strategic and planning alignment across ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… more
- Merck & Co. (Rahway, NJ)
- …introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk ... of work, holding the team accountable to deliver on priorities. Document preparation, maintenance, and review of documentation including specifications, testing… more
- Merck & Co. (Durham, NC)
- …maintain own training status and ability to train others. Participate in document design activities working alongside operations team members to develop reliable, ... Operations, Good Manufacturing Practices (GMP), In-Process Control (IPC), Maintenance Management , Maintenance Processes, Manufacturing Processes, Manufacturing Process Improvements, Manufacturing… more
- Repligen (Waltham, MA)
- …supplier changes. Nonconforming Material Request (NCMR) Process and AnalysisInitiate and Document NCMRs: Identify and document nonconforming material detected ... assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and corrective action… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior ... a job environment with physical dexterity sufficient to use computers and document production records.Ability to handle human derived materials in BSL-2 cleanroom… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interests and business needs in shaping development and life cycle management strategy for select indications/projects. Reviews Externally Sponsored Research (ESRs) ... evidence generating studies/projects. Manages all medical aspects such as study document development and drives execution for assigned projects in collaboration with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …gets to work on this. You have strong knowledge of cGMP requirements. You document proposals to reach a solution with relevant stakeholders (eg QA, C&Q, Operations, ... CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You will also write SOPs (Standard Operating Procedures) and… more
- Eisai, Inc (Exton, PA)
- …and Wonderware SCADAs. Maintaining the systems includes utilizing the appropriate change management mechanisms to improve and verify system function as well as ... and deliverables (drawings, specification, etc.) Lead team review of designs and document decisions. Responsible for the design of new applications. Prepare small to… more
