- Fresenius Medical Center (College Park, GA)
- …maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to… more
- Chiesi (Boston, MA)
- …+ Proficient in the use of quality management software (eg TrackWise) and regulatory document information management system is an asset. + Strong attention ... of CMC submission templates. + Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for… more
- MD Anderson Cancer Center (Houston, TX)
- …process, etc.) Communicates with applicable sponsors regarding clinical trial regulatory document submissions. Creates, updates, and oversees maintenance ... audit, or inspection visits. Assists in development and maintenance of a regulatory document control system. Participates in developing departmental processes… more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site… more
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as Veeva Systems products, ... programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research...the Electronic Common Technical Document (eCTD), etc. is a plus. Resume and cover… more
- Takeda Pharmaceuticals (Columbus, OH)
- …book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory ... you and empower you to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global … more
- IQVIA (Parsippany, NJ)
- …to clients; * Provides mentorship to junior colleagues and advise others on many regulatory document types; * May plan and deliver workshops or presentations on ... Job Overview Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is… more
- Amgen (Washington, DC)
- …USRL + Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory ... of patients while transforming your career. **Senior Associate** - ** Regulatory Affairs** **What you will do** Let's do this....this. Let's change the world. The Senior Associate in Regulatory Affairs at Amgen plays an important role in… more
- University of Miami (Miami, FL)
- …include, but not be limited to: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...CORE JOB SUMMARY: The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting… more
- University of Miami (Miami, FL)
- … regulatory submissions. CORE JOB FUNCTIONS + Facilitates the process of regulatory document submissions to various boards, committees, industry sponsors, and ... Pulmonary Medicine, has an exciting opportunity for a full-time Regulatory Specialist to work on the UHealth campus. The... Specialist to work on the UHealth campus. The Regulatory Specialist assists with the preparation and maintenance of… more
- University of Miami (Miami, FL)
- …and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance + Serves as point of contact for various ... University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the...Palmer Eye Institute in the Department of Research. The Regulatory Analyst will be responsible for conducting the on-site… more
- University of Miami (Miami, FL)
- …provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, ... review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Remote SCCC Regulatory Analyst II reviews, prepares, and provides oversight for… more
- Sumitomo Pharma (Columbus, OH)
- …strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary ... a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory … more
- Scotiabank (Houston, TX)
- …Working knowledge of the reporting tool (Axiom) used by the department to produce the regulatory filings. + Document and monitor issues related to system / data ... Manager, Regulatory Reporting **Requisition ID:** 214093 **Salary Range:** 90,000.00...every future! **Purpose** In this role as a Manager, Regulatory Reporting, you will contribute to the overall success… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking and to ensure ... **Job Description** The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy… more
- Tutor Perini (White Plains, NY)
- …and retrieved in compliance with the Contract requirements, company policies, and regulatory requirements. The Document Control Specialist is critical in ... ** Document Control Manager - Kensico-Eastview Tunnel Project** Office...Code **2549** Frontier-Kemper, a Tutor Perini Company, is seekinga ** Document Control Manager** to join our Kensico-Eastview Connection Tunnel… more
- ICF (Los Angeles, CA)
- …tariffs to inform design of programs and pricing strategies. + Observe and document regulatory proceedings, participate in forums that inform utility planning ... Description **Senior Regulatory Advisor - California Energy and Decarbonization** **Location:**...Angeles office) **Ready to make a difference?** As the Regulatory Manager you will be responsible for actively engaging… more
- ACLD (Bethpage, NY)
- …procedures, guidelines and regulatory requirements. * Conduct and document Regulatory Affairs activities including Billing and Documentation reviews ... Regulatory Affairs Senior Analyst When a group of...we support. Primary Purpose of Job Assess and support regulatory compliance and the quality of service delivery systems.… more
- Aerotek (Centennial, CO)
- …editing. + 3-5 years of experience in processing federal documents and transmitting regulatory documents. + Experience with document sizes ranging from 2,000 to ... **Job Title: Document Processor** **Job Description** We are seeking an... Processor** **Job Description** We are seeking an Administrative Professional/ Document Processor to provide document processing and… more
- LSI Solutions (Victor, NY)
- …assigned. Level II + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + ... opportunity for you to take that skillset and branch out into the area of regulatory . We are seeking a person who is highly organized and detail-oriented to become a… more
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