- Transdev (Readville, MA)
- …effectively with diverse groups. Ability to effectively communicate with regulatory agencies, community organizations and others. Ability to effectively interact ... in an appropriate manner, and to effectively communicate with regulatory agencies, community organizations, and others on technical and...moderate. The job requirements and duties outlined in this document may be subject to change to meet the… more
- Exact Sciences (Madison, WI)
- …and monthly building inspections to assess the current operational condition, document findings, and take appropriate follow up action following applicable ... equipment to improve safety, performance, and reliability. Maintain compliance with all regulatory standards, including but not limited to GMP, OSHA, FDA and USDA.… more
- Ochsner Health System (Lydia, LA)
- …to treatment sessions according to the Progressive Mobility Protocol (PMP) and document in EPIC. * Assist with equipment inspection, maintenance, and storage, ... knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility… more
- Memorial Health (Springfield, IL)
- …Works with Facilities and Engineering staff to gather data necessary to document existing building systems on electronic drawing system. 10. Maintain drawing ... documentation. 11. Works with Facilities leadership to develop format to document existing building systems on electronic drawing system. 12. Provides assistance… 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 eFlorence, Veeva Systems ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
- Takeda Pharmaceuticals (Boston, MA)
- … authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. + Experience with regulatory ... knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory...regulatory processes and technology for submission document… more
- Dana-Farber Cancer Institute (Boston, MA)
- …compliance for the disease group. Implementing systems to monitor and ensure regulatory document collection and maintain compliance and audit-ready state. Assist ... relevant to children with cancer and blood disorders. CTIP Regulatory unit will provide pan-CTIP support as part of...support as part of our clinical research infrastructure. CTIP regulatory unit will support interventional studies to the IRB… 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, ... studies: JOB FUNCTIONS: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation… 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 eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site… 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
- Roche (Indianapolis, IN)
- …global markets, primarily the US and Europe. **The Opportunity** + You oversee regulatory document and submission compilation, which includes the development of ... love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best... Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)_ + Obtain input from the global regulatory team… more
- Sumitomo Pharma (Honolulu, HI)
- … strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
- ICON Clinical Research (NC)
- …experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical ... Senior Manager, Regulatory Affairs - IVD ICON plc is a...to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR… more
- AECOM (Sacramento, CA)
- …archival activities to ensure compliance with standards, contractual requirements, and regulatory obligations + Ensure adherence to document control procedures, ... management (eg, CDIA+, CRM) or equivalent + Familiarity with audit processes, regulatory compliance, and document retention requirements + Experience supporting… more
- Kelly Services (Philadelphia, PA)
- …workflows and documentation guidelines. + Draft and ensure high quality technical regulatory documents + Create electronic document versions (Word, PDF, etc.) ... + Import/export documents into Veeva Regulatory One following document management rules + Define metadata (properties) for each document and align according… more
- Actalent (New Richmond, WI)
- …and documents for accuracy, completeness, and adherence to quality and regulatory requirements. + Perform document management, tracking, and administrative ... Job Title: Document Control Animal TechnicianJob Description This role combines...Control Animal TechnicianJob Description This role combines responsibilities in quality/ document control and animal husbandry support. You will perform… more
- Actalent (Maplewood, MN)
- …and documents for accuracy, completeness, and adherence to quality and regulatory requirements. + Perform document management, tracking, and administrative ... Job Title: Document Control Animal Technician Responsibilities + Support quality...support tasks for controlled document record systems. + Coordinate document control… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …product lines, aligning with overall business objectives. + Review, approve, and document regulatory changes to commercialized devices. + Identify and ... Summary** This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business. This role… more
- ACLD (Bethpage, NY)
- …throughout Nassau and Suffolk Counties. Essential Functions + Conduct and document Regulatory Affairs activities including Billing and Documentation reviews ... Regulatory Affairs Analyst When a group of families...we support. Primary Purpose of Job Assess and support regulatory compliance and the quality of service delivery systems.… more
