- Repligen (Hopkinton, IA)
- OverviewWe are seeking a Document Control/QA Associate I to join our growing Quality Department team in Hopkinton, MA for 1st shift operations (M-F) from 8 am EST - ... 4:30 pm EST.The Document Control/QA Associate I will report directly to the...Management System. This role is responsible for assisting the document control department in processing documentation requests. They will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/ Document Audits supports end-to-end audit activities per audit program of GxP ... as appropriate for the area of GxP audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document … more
- Aequor (Athens, GA)
- …/ activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy systems. Electronic ... Document Management (controlled documents, regulatory submission documents): Create and...Management (controlled documents, regulatory submission documents): Create and configure document templates and support site users in workflow configuration.… more
- Merck & Co. (Rahway, NJ)
- …responsible for preparing responses to Internal Revenue Service Information Document Requests ("IDRs"), gathering information, preparing analyses to support ... gather necessary information.Key ResponsibilitiesPrepare detailed responses to IRS Information Document Requests (IDRs), ensuring all information is comprehensive and… more
- Merck & Co. (North Wales, PA)
- …care systems that can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical need, patient reported ... and reimbursement dossier, which includes the development of the worldwide template document including global value dossier and input forms, design of data… more
- Merck & Co. (South San Francisco, CA)
- …development. PDMB aims to leverage Generative AI (GenAI) to enhance document authoring processes, thereby improving efficiency and compliance in regulatory ... review process. -Implement strategies to leverage GenAI for improving document quality and consistency.Education Minimum Requirements: -Ph.D. in Computer Science,… more
- Merck & Co. (Upper Gwynedd, PA)
- …communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.Provide regulatory leadership as needed in product ... Biological Sciences, Biologics License Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance, Microbiology, Molecular Microbiology,… more
- Aequor (Pearl River, LA)
- …from raw data acquisition to data visualization and data analysis. Develop, document , and maintain reproducible computational pipelines and scripts using R and ... to detail in managing multiple projects and deadlines. Ability to document code thoroughly to ensure reproducibility and clarity for collaborative projects.Hard… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Formation Bio (New York, NY)
- …within transformation layers-using LLMs for named entity recognition, document summarization, classification, and schema alignment. Write robust, testable, ... frameworks to ensure quality, trust, and reproducibility of datasets. Document transformation logic, assumptions, and data lineage in collaboration with… 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 ... experience.Excellent communication, collaboration, and relationship-building skills.Ability to gather and document detailed business requirements and work with users to… more
- Merck & Co. (Boston, MA)
- …current with emerging pharmaceutical information tools and databasesSupporting document delivery requests and end-user requestsObtaining journal articles and ... book chapters for internal stakeholders and agency partnersAssisting with negotiations of subscribed content under the direction of the DirectorTracking and triaging support and training requests with Library team membersManaging access to external information… more
- Twist BioScience (South San Francisco, CA)
- …and collaborate with the Business Process Owner and EQMS users to develop and document configuration changes to meet business need Perform other duties & projects as ... SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience with Google Suite and/or MS Office… more
- Merck & Co. (Rahway, NJ)
- …Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, Document Control Systems, Electronic Common Technical Document ... (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance Team Building, Human Resource Management, Immunoassays, Immunology, Immunotherapy, Management Process, Medical Devices, Mentoring Staff, Ophthalmology, Pathophysiology,… more
- Repligen (San Diego, CA)
- …the CTI/Repligen Sales Force with testing, reporting and customer interactions. Document activities on the CTI/Repligen CRM software platforms & deliver ... all post-visit findings to appropriate internal stakeholders.Opportunity to learn and service additional Repligen instrumentation.QualificationsBachelor's degree in a related field (eg Biology, Chemistry) or equivalent lab experience.1 year of experience… more
- Merck & Co. (Rahway, NJ)
- …best practices, processes, and procedures.Use our DCIM tool Sunbird to document , design, and plan IT equipment installations for our Technology Spaces.Qualifications ... Required 5+ years operating and supporting enterprise DC environments with 24x7x365 uptime requirements.5+ years' experience designing and deploying Technology Spaces supporting servers, storage, and virtualization technologies across multiple vendors in a… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …the ability to follow written standard operating procedures and the ability to document work in accordance with Good Laboratory Practices (GLP). Must also be able ... to work with chemicals such as Xylene, Alcohols, formalin, and other tissue fixatives.Requires strong written and verbal communication skills, the ability to work independently and as a part of a team. Must have working knowledge of Microsoft Office, as well… more
- Eisai, Inc (Nutley, NJ)
- …clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and maintaining ... project trackers in EPICProvides support for document preparation and follow-up (eg Informed Consent Form, eTMF fling plan, Co-Monitoring Plan)Creates Clinical Trial… more
- Repligen (Hopkinton, IA)
- …Cause Investigations.Good organization skills and Microsoft Office software to accurately document and maintain associated paperwork and inspection results in a ... consistent and timely fashion.Identify and communicate continuous improvement opportunities for the quality program for customers internal and external.Maintain clean and orderly work area/ station. Comply with safety regulations and personnel policy. Other… more
- Merck & Co. (Rahway, NJ)
- …Strategy Development, Confidential Data Handling, Database Management, Document Management, Event Planning, Facility Management, Fast-Paced Environments, ... Interpersonal Relationships, Microsoft Office, Process Improvements, Processing Expense Reports, Purchase Order Management, Reporting and Analysis, Scheduling, Task Management, Travel Expertise, Vendor Management, Working Independently-Preferred Skills:Job… more
