- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the authoring and lifecycle management of all GCO-owned procedural document packages, ensuring they are clearly and effectively written and maintained, ... Management:Responsible for the ownership and maintenance of GCO-owned procedural document packages.Lead authoring, review, and periodic reviews/updates for all GCO… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO).Contribute to operational delivery aspects of the protocol and take a document review & coordination role for the protocol and amendments. Additional medical ... trial and site level documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial...the Trial master File (TMF). Reconcile the CRO-generated TMF document trackers with the document archive. Identify… 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
- 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
- Merck & Co. (North Wales, PA)
- …can enhance value and use of our company's products. Implement programs to document the burden and cost of diseases, unmet medical need, patient reported outcomes ... and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data… more
- Aequor (San Diego, CA)
- …The IT Analyst works closely with IT Business Partners to define and document key processes, requirements, knowledge articles, and user documentation. The IT Analyst ... Work with Business and IT Business Partners to help define and document business processes and requirements including, but not limited to, data flow,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the TMF document trackers generated by the CRO with the document archive. ... 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. (North Wales, PA)
- …and communication to users.You will apply a structured approach to discover, document , and manage business process and stakeholder needs. You will also gather ... will:Gather documentation related to the business process in clinical domain, document business/user needs and trace requests and responses to requests.Continuously… more
- Drainage Solutions Inc. (Franklin, IN)
- …to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills or abilities. This document ... does not create an employment contract, implied or otherwise, other than an "at will" relationship. Document Reviewed Date: June1, 2024 more
- Drainage Solutions Inc. (Franklin, IN)
- …to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills or abilities. This document ... does not create an employment contract, implied or otherwise, other than an "at will" relationship. Document Reviewed Date: June 1, 2024 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)
- …of experience in the areas of training, and systems ( document and slide development/centralization; activity logs/reporting; other) including training certification ... preferredExperience in the areas of organizational effectiveness and systems ( document and slide development/centralization; activity logs/reporting; other) preferredPrevious experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …objectivity and discretion in the observation and collection of facts. Conducts document collection, document and information review, interviews and/or other ... reviews of persons involved in or having knowledge of a particular situation, in accordance with the established protocols.Ensures closeout reports and/or other documentation of outcome of particular cases including but not limited to investigative logs.… more
- Merck & Co. (North Wales, PA)
- …and validation plansParticipate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to ... of study data for reports and publicationsUnderstand, coordinate, and document adherence to internal, external, and regulatory compliance requirementsCollaborate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach ... messages, and review and author safety sections of Common Technical Document (CTD). May oversee multiple simultaneous submissions to ensure harmonized approach… 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
- Aequor (Thousand Oaks, CA)
- …be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media ... Office expertise; previous technical writing experience; regulated environment experience; document version control experience; excellent communication/writing skills Responsibilities Own… more
- Shimadzu Scientific Instruments (Boston, MA)
- …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 (Washington, DC)
- …harmonization of sales through the Japanese Trading Companies network. 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
