Performs eCTD submission management across Biogen's 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 Biogen 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.
...
...Primary Care Physician or Mid Level. Candidates must have strong experience with Medicare Advantage patients and coding for STARS & HEDIS measures. Competitive base and compensation package. 12-15 patients per day. If interested please forward a CV....
Overview: Salem Media - Atlanta offers an exceptional opportunity for a Media Strategist / Account Executive. We are looking for a highly... ...motivated sales professional to join our growing on-air and digital sales team. The individual who is hired will sell and manage our...
...Job Posting: Sales Development Intern Company: Varonis Systems, Inc. Summary:... ...working environment, along with free food, a game room, and various social events. Through our... ...impact. We invite you to check out this video and our Instagram Page to gain further...
...Premier Medical Staffing Services is seeking a travel Cath Lab Technologist for a travel job in Austin, Texas. Job Description & Requirements ~ Specialty: Cath Lab Technologist ~ Discipline: Allied Health Professional ~ Start Date: ASAP ~ Duration: 13 weeks...
Registered Nurse Care Manager / Case Management (RN) at ScionHealth summary:The Registered Nurse Care Manager coordinates and provides nursing care for patients in post-anesthesia care at St. Francis-Emory Healthcare. The role involves planning, documenting, and evaluating...