Inizio Evoke

Regulatory Operations Coordinator

Inizio Evoke

full-time

Posted on:

Location Type: Remote

Location: Pennsylvania • United States

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Salary

💰 $58,000 - $65,000 per year

Tech Stack

Vault

About the role

  • 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

Requirements

  • 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
  • Inizio Evoke offers a fully remote work environment and outstanding company-paid benefits, including medical, dental, 401(k), tuition reimbursement, and flexible time off.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SnaggingScreenshottingFunctional annotationsPDF review documentationSubmission review routesMLR job codesArchivingDigital asset uploadSubmission package preparationProject Dashboard updates
Soft Skills
Deadline-drivenAdaptableMultitaskingDetail-orientedProactive communicationOrganizedCollaborativeSolutions-orientedCalm under pressureProcess-minded