Pay is commiserate with experience and ranges between $58-63/hr
Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products. Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality. Responsible for electronic submissions and documents meeting regulatory agency and the companies submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines. Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. Competent in the use of electronic document management and submissions publishing tools. 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe. Experience overseeing publishing vendors preferred.Description We are looking for a detail-oriented Part - Time Accountant to join our team on a part-time contract basis in Brooklyn Park, Minnesota. In this role, you will contribute to a variety of accounting and administrative tasks, ensuring the smooth operation of...
...conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience. Employee Benefits: At BAE Systems, we support our employees in all aspects of their life, including their health and financial well-being. Regular employees...
...MN Job Description Looking for a part-time babysitter near UMN for 2 kids. Must have... ...Enrollment: Yes Qualifications A love of working with children Excellent communication... ...Connect with other college students and build relationships Get paid on a...
...join our Communications department on the Creative team to provide design and administrative support to staffs. Note: This internship is in-person at our New York City office. Responsibilities: The intern will assist with graphic design, archival and...
...DESCRIPTION Join Amazon's dynamic environment as a Senior Supply Chain Manager with a planning background, where you will play a crucial role in shaping and optimizing various facets of our operations, concentrating on optimizing and managing the flow of goods, information...