- Eisai, Inc (NJ)
- …MS project and MS Word and Experienced in the use of a document management system#LI-HC1#IND-123Eisai Salary Transparency Language:The base salary range for the ... clinical and submission documentation across all aspects of the compounds' life cycle management , with support from management as needed. The qualified candidate… more
- Aequor (Thousand Oaks, CA)
- …skills and experience navigating a matrixed organization Working knowledge of document management applications and study planning tools (eg. Planisware, ... to any experience level. (2&plus years experience) LIMS (laboratory information management system) and a basic understanding of clinical trials understanding, and… more
- Novo Nordisk Inc. (Boulder, CO)
- …forms (injectables) preferred Experience with Veeva Vault or similar electronic document management system preferred Strong attention to details, organizational ... Collect and maintain monthly product quality metrics data for QA Management Maintain systems used for tracking various GMP manufacturing associated support… more
- Aequor (Thousand Oaks, CA)
- …computer software such as MS Office (ie, Excel, Word, Project), LIMS, document management systems, regulatory application systems, etc. Experience working on ... subject matter expert of clinical and commercial product stability studies and GMP data management . In this team-based role, you will directly add to the success of… more
- Aequor (Devers, TX)
- …disposition of incoming materials. Works in electronic systems such as SAP, Learning Management , and Document management systems. May contribute to drafting, ... to support disposition of materials and batches within the inventory management systems. Assure materials comply with all Client policies, standards, Network… more
- Aequor (Seattle, WA)
- …minimum 1 year of experience in a regulated environment. Experience with Quality Document Management Systems and Learning management systems. Proficient in ... Role based curriculum experience ADDIE experience Kirkpatrick experience Learning Management System (LMS) Articulate Rise experience Responsibilities: Partner with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Cycle Management , will be accountable for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly ... package or any needed procedural document and/or procedural document package update(s). Cross-Functional Procedural Management Related to Vendor Alliance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …instrumentation, and computerized systems.Knowledge of quality systems including exception management , change control, document control.Knowledge of operating ... and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.Able to write detailed investigation summary memos that meet the requirements of the Quality… more
- Aequor (Thousand Oaks, CA)
- …monthly SLA reporting and dashboard creation Assist with training document updates Additional responsibilities may be assignedPreferred Qualifications 6&plus years ... of experience in contracts, project and change management Paralegal experience Knowledge and understanding of internal control framework, contracts, finance and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within the laboratory. Take the lead in managing Equipment Lifecycle Management processes, including overseeing change control procedures. Document and ... multiple myeloma. Legend Biotech is seeking QC Specialist, Equipment Management as part of the Quality team based in...in Raritan, NJ. Role Overview The QC Specialist, Equipment Management is responsible for equipment lifecycle management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specifications for Veeva CRM. Collaborate with business stakeholders to gather and document business needs, objectives, and processes related to Veeva CRM as it ... experience required) in and out of Veeva CRM system.- Documentation: Document various system related documentations such as system configurations, data flow… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …training program.Leadership, support and system administration for the FMA knowledge management system(s) The Associate Director will also be responsible for ... strategic planning and project management for projects aimed at developing training materials, tools or other programs to advance the effectiveness of… more
- Aequor (Seattle, WA)
- …and Technology function, this position is accountable for the end to end management for method transfers & validations for the Cell Therapy Organization for ... portfolio (methods for release and in-process controls in scope) Operational management lead for the implementation of method lifecycle and method maintenance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Practice (GCP) to ensure adherence/compliance Plan, oversee, coordinate , conduct and document all Safety new hire training programs, including local and global ... and nuances to deliver training effectively In collaboration with Patient Safety Management re- training to Patient Safety employees on specific training objectives… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …protection and privacy laws, utilizing various elements of DSI's Privacy management program elements (eg policies, guideline, standards, tools, procedures, self-help ... objectivity and discretion in the observation and collection of facts. Conducts document collection, document and information review, interviews and/or other… more
- Haleon (Independence, KS)
- …review, as well as global operations (eg, Exterro or Relativity, Legal matter management , document management tools) & related systems configuration. ... products supporting the business comply with internal security and risk management policies.Adhering to external regulatory and statutory requirements (eg, GxP,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and ... PSL(s) to proactively plan and prioritize safety surveillance and risk management activities for assigned product(s), including resource planning, oversees team's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical Safety ... (SME) in one or more focus areas May start to develop people management skills by mentoring and coaching junior Clinical Safety Scientists or post-doctoral fellows… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to another. This position involves collaborating with various teams to gather, document and implement solutions across various HRIS technologies, ensuring a focus on ... as the principal functional expert and advisor for implementation and ongoing management and maintenance of the Company's global HRIS system (ie, SAP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the solution will meet the business requirements. Provide project management responsibilities as necessary.- Organize and facilitate problem-solving discussions with ... and existing functionality. Responsible for the development of the Technical Design Document to ensure all requirements have been met. Responsible for reviewing unit… more
