- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document Control ... (QADC) Supervisor. The QADC Supervisor will supervise the team and activities associated with batch record documentation, reviewing and approving batch records, and releasing batch records and finished product. They will have a deep understanding and values… more
- Aequor (Seattle, WA)
- …Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). Experience in data analysis ... Demonstrated proficiency in MS Project, PowerPoint, Excel, Word, and Document Managements Systems (Veeva Vault preferred). Experience in data analysis… more
- Eisai, Inc (NJ)
- …will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions ... Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues etc.With minimal supervision, preparing and/or… more
- Aequor (Newbury Park, CA)
- …regulatory submissions including IND, sIND, BLA, and sBLA useful. Use of document archival systems/electronic document repositories also useful. Coordination and ... Excel, PowerPoint) Technical competency for data entry into electronic document management systems, SharePoint sites and other databases/trackers. Preferred Skills:… more
- Merck & Co. (North Wales, PA)
- …requirements. Applies an in-depth knowledge of medical writing responsibilities, including document planning and authoring, and interpretation of data. Is a ... scientific contributor and works collaboratively on document -specific cross-functional teams while demonstrating an understanding of team and project leadership… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Investigating prosecution related issues in PAIR and other patent document management systems Independently communicating with patent authorities, agents, and ... electronic storage and management of documents in electronic patent document management systems Managing and supporting data/docket management functions. Providing… more
- Insmed Incorporated (Bridgewater, NJ)
- …submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission ... related documents in the Company's electronic document management system (EDMS).ResponsibilitiesRESPONSIBILITIES:Support regulatory submission activities associated with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …samples in freezers/refrigerators. Periodic inspection and consolidation of retains. Document and perform sample management related non-conformance investigations. ... regulatory requirements, policies and guidelines. Experience with Quality Control document reviews and regulatory inspection processes. Working knowledge of Quality… more
- BioAgilytix (Durham, NC)
- …processes and procedures for managing external vendors for archiving services and document flow of outgoing and incoming archived data to external vendor Collaborate ... for the archive room Scan and post Archive Employee Signature pages, document date of termination, and archive when appropriate Move Reagent Preparation electronic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF document trackers generated by the CRO with the document ... information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and… more
- Merck & Co. (Rahway, NJ)
- …systems in the manufacturing and lab print environment including label and document printing using infrastructure applications such as HPOM, LRS VPSX, windows print ... and other quality standards are met.Change Control Experience - ability to develop, document , and implement changes based on requests for change (in agile or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lead role in the audit/inspection process (eg, prepare pre-audit requests, perform document review, coach auditees, manage document requests, front room auditee, ... messenger, scribe) Collaborate with Global Safety to align on case handling instructions across safety sites by attending relevant global meetings and coordinating dissemination of information and actions Ensure timely registration of deviation(s) and… more
- Merck & Co. (Rahway, NJ)
- …the entire platform release lifecycle by working with a TEAM, define and document requirements, document personas, use cases and process flows, perform testing ... and oversee full release cycles.Create mock-ups, swim lanes and process maps to assist with the business process engineering and improvements.Create satisfying and compelling experiences for users working with products, often drawing on results from user… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and maintenance of business requirements, support user acceptance testing, and document processes aligned to the needs of customers (HCPs, Patients, Health ... Marketing, Field Force) Collaborate with internal stakeholders to gather and document business requirements to deliver on solutions that bring value, optimize… more
- Shimadzu Scientific Instruments (Baltimore, MD)
- …responsible for repair, maintenance and installation of assigned products. This document attempts to communicate the traditional, physical and environment demands ... protective equipment and safety devices as required by the Corporate Safety Document policies and procedures and/or customer dictated policy. WORK ENVIRONMENT: This… more
- Shimadzu Scientific Instruments (Pittsburgh, PA)
- …exceed assigned sales goals within an assigned geographic territory. This document attempts to communicate the traditional, physical and environment demands ... protective equipment and safety devices as required by the Corporate Safety Document policies and procedures and/or customer dictated policy. WORK ENVIRONMENT: This… more
- Shimadzu Scientific Instruments (Los Angeles, CA)
- …Scientific Instruments anywhere within our market area as required. This document attempts to communicate the traditional, physical and environment demands ... protective equipment and safety devices as required by the Corporate Safety Document policies and procedures and/or customer dictated policy. WORK ENVIRONMENT: This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that meet functional / non-functional business requirements Excellent technical writing, document organization, technical document review and analytical thinking ... skills are required Demonstrated problem solver with an ability to provide technical solutions to a wide range of complex problems Excellent interpersonal, negotiation, written and oral communication skills Expert knowledge of systems analysis and design… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to Company-wide trainings and external/global trainings, as appropriate.Maintain systems and document training curricula to ensure that only current training modules ... of existing policies and procedures.Maintain current and accurate systems for document sharing.Building Relationships -the position is responsible for building and… more
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