[Remote] Regulatory Operations Coordinator
Note: The job is a remote job and is open to candidates in USA. Inizio Evoke is a dynamic global healthcare platform focused on making health more human. 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 all 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 all documents needed for a submissions package
- Set up, start, monitor and gain 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 excel 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 all 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 all documents needed for a submissions package
- Set up, start, monitor and gain 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 excel sheet with upcoming and completed submissions
- Attend project Kick offs and review timelines as needed by manager
- Highly deadline-driven
- Adaptable and flexible, able to quickly adjust to shifting timelines, priorities, and client needs
- Strong multitasker who can balance concurrent 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 complex workflows and documentation efficiently
- 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 mindset with a focus on improving processes and increasing efficiency
- Ability to remain calm and focused under pressure, especially during tight deadlines and submission cycles
Benefits
- Medical
- Dental
- 401(k)
- Tuition reimbursement
- Flexible time off
Company Overview