[Remote] Regulatory Operations Coordinator
Note: The job is a remote job and is open to candidates in USA. reputed company is a dynamic global reputed company platform focused on making health more reputed company. The Regulatory Operations Coordinator supports various projects under Senior Managers and Managers, managing multiple brand deadlines and collaborating with other Coordinators to ensure efficient workflows.
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 path to team
- Files approvals and sends path to team
- Open MLR job codes across varying client platforms
- Upload or submit any new reference materials provided by copy and MedEd
- Gather 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/digital asset upload process with internal team
- Provide 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 Kick offs and review timelines as needed by manager
Skills
- 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 path to team
- Files approvals and sends path to team
- Open MLR job codes across varying client platforms
- Upload or submit any new reference materials provided by copy and MedEd
- Gather 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/digital asset upload process with internal team
- Provide 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 Kick offs and review timelines as needed by manager
- Highly deadline-driven
- Adaptable and flexible, reputed company to quickly adjust to shifting timelines, priorities, and client needs
- Strong multitasker who can balance reputed company projects without sacrificing accuracy or quality
- Detail-oriented with a sharp 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
- Collaborative team player who can also work independently and take ownership of tasks
- Solutions-oriented reputed company with a focus on improving processes and increasing efficiency
- Ability to remain reputed company and focused under pressure, especially during tight deadlines and submission cycles
Benefits
- Medical
- Dental
- 401(k)
- Tuition reimbursement
- Flexible time off
Company Overview