- Insmed Incorporated (NJ)
- …management best practices.Contribute to process improvements and operational efficiencies in regulatory publishing and document management .Who You Are:You ... to manage multiple projects with competing priorities.High technical aptitude for regulatory publishing and document management systems.Detail-oriented with… more
- Insmed Incorporated (NJ)
- …submissions and correspondence and archive regulatory files using Veeva Vault Document Management System Who You Are:You have a Bachelor's degree along ... for assigned projects including project timeline planning and documentation workflow management for global regulatory documents (including but not limited… more
- Parexel (Trenton, NJ)
- …practice Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... lead the development of appropriate responses. Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. Electronic document … more
- Parexel (Providence, RI)
- …+ Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... the development of appropriate responses. - Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. + Electronic document… more
- Eisai, Inc (Bethesda, OH)
- …and data standards (eg, CDISC).Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (eg, ... Submission Heads for additional support for resources when needed. Provides the Regulatory Submission Management for a lead compound or submission project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The ideal candidate will have a strong background in documentation management , process oversight, and regulatory compliance within the pharmaceutical ... etc.); advanced degree preferred 7+ years of experience in documentation management , quality assurance, or regulatory compliance within the pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …Leadership, the Senior Specialist, Regulatory Authoring Business Analyst,-will optimize regulatory authoring processes and enhance data management by mapping ... errors, and enable digitization. Experience in digitization and data management initiatives in regulated environments, including source- document … more
- Cipla (Fall River, MA)
- Job Title : QA Document Control Associate FLSA Classification : Full-Time, Professional Work Location : Fall River, MA Work Hours: General Shift: 08:30 AM - 5:00 PM ... Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a pharmaceutical environment is responsible...controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11,… more
- Twist BioScience (South San Francisco, CA)
- …Synthetic Biology Manufacturing, and Gene Manufacturing highly desirableExperience with document management systems required.Experience with Learning ... multiple levels within all functional departments, including Quality Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control, Production,… more
- Takeda Pharmaceuticals (Boston, MA)
- …managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking ... empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Oncology TAU within our Global … more
- Abbott (Waukegan, IL)
- …reporting, operations, and decision making for the Quality Non-Complaints, LMS (Learning Management ), DMS ( Document Management ), and Global Engineering ... compliance with applicable Corporate and Divisional Policies and procedures. Management Responsibilities Responsible for all aspects of people leadership; setting… more
- CTG (Buffalo, NY)
- …mortgage and loan documents within the custodial vault. Perform comprehensive document audits to ensure completeness, accuracy, and regulatory compliance. ... to high-quality work. Education and Experience Preferred: Prior experience in document custody, records management , financial services, or vault operations.… more
- Merck (Harrisburg, PA)
- …the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring processes and enhance data management by mapping workflows, ... errors, and enable digitization. Experience in digitization and data management initiatives in regulated environments, including source- document … more
- Integra LifeSciences (Princeton, NJ)
- …and oversee quality and compliance improvement and remediation strategies for document and record control, change management , and training administration ... and set new standards of care. The Sr. Manager, Document Control and Training is responsible for leading the...and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design,… more
- Deloitte (Arlington, VA)
- …information and respond to regulatory or litigation requests. + Performs document management and review functions such as reviewing files, preparing indexes, ... service of process. + Inputs data, maintains and updates OGC's litigation matter management system and its service of process tracking database. + Circulates copies… more
- Deloitte (Washington, DC)
- …gather information and respond to regulatory or litigation requests. Performs document management and review functions such as reviewing files, preparing ... service of process. Inputs data, maintains and updates OGC's litigation matter management system and its service of process tracking database. Circulates copies of… more
- Wells Fargo (Charlotte, NC)
- …of CRE lending bilateral and/or syndicated focusing on loan documentation and deal management . In this role, you will: Prepare, negotiate and track various legal ... transactions with bank counterparties. Work on various projects as requested by management . Interpret policy when working with legal, credit and the relevant… more
- Oracle (Salt Lake City, UT)
- …data pipelines). These engineers will be dedicated to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering ... risk management files , hazard analyses, and FMEAs. Collaborate with Regulatory , MDR Program leadership, and Risk Management TPMs to align documentation… more
- Otsuka America Pharmaceutical Inc. (St. Paul, MN)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). Competencies See OPDC Competencies Chart ... Position Summary Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug… more
- Sumitomo Pharma (Hartford, CT)
- …will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA ... affairs activities; provide relevant input to Leadership Oversee the regulatory activities at CROs, providing document review...Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and… more
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