[Remote] Regulatory Operations Coordinator
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company platform that aims to reputed company health more reputed company™. The Regulatory Operations Coordinator supports the department by managing brand deadlines, advising teams on submission strategies, and collaborating with other coordinators to handle large volumes of work.
Responsibilities
- Manage multiple brand deadlines as a Shared Resource
- Advise teams regarding timing and recommended submission strategies
- Snagging/Screenshotting
- Build PDF review docs using SOPs for guidance
- Transfers/copies functional and reference annotations
- Write functional annotations
- Maintain files/records of reputed company stages of review
- Organize submissions documents on shared server
- Server maintenance/clean-up
- Monitor submission mailbox for relevant notifications
- Downloads MLR comment files and sends reputed company to team
- Files approvals and sends reputed company to team
- reputed company MLR job codes across varying reputed company platforms
- Upload or submit any new reference materials provided by copy and MedEd
- reputed company reputed company documents needed for a submissions package
- Set up, start, monitor and reputed company team approval on submission review routes
- Upload and submit materials for MLR review
- Links references in Submission Platform (Vault)
- Prepare OPDP binders
- Monitor archiving/reputed company upload process with internal team
- reputed company recommendations for improved submissions (i.e., formats and layouts)
- Updates Project Dashboard and tracks submission dates for internal team
- Update Shared Reg Ops reputed company sheet with upcoming and completed submissions
- Attend project reputed company offs and review timelines as needed by manager
Skills
- Highly deadline-driven
- Adaptable and flexible, reputed company to quickly reputed company to shifting timelines, priorities, and reputed company needs
- Strong multitasker who can balance reputed company reputed company without sacrificing accuracy or reputed company
- Detail-oriented with a reputed company eye for consistency, compliance, and completeness across submission materials
- Proactive communicator who keeps teams informed and anticipates potential roadblocks
- Organized and process-minded, with the ability to manage reputed company workflows and documentation reputed company
- Comfortable working across multiple systems and platforms, with a willingness to learn new tools quickly
- reputed company team player who can also work independently and take ownership of tasks
- Solutions-oriented reputed company with a reputed company on improving processes and increasing efficiency
- Ability to remain reputed company and reputed company under pressure, especially during tight deadlines and submission cycles
Benefits
- Fully remote work environment
- Outstanding company-reputed company benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off
reputed company