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Regulatory Operations Coordinator

2 hours, 17 minutes ago
United States
Full-time
Junior
Operations Specialist
Project and Program Management
Apply Now
Inizio Evoke

Inizio Evoke

Inizio Evoke is a global health marketing and communications platform that focuses on transforming healthcare by leveraging data-driven insights and human-centric strategies to enhance patient support and market access solutions.

Professional Services
Founded 2000
View All Jobs 29

Description

  • Manage multiple brand deadlines as a shared resource across the department.
  • Advise teams on timing and recommended submission strategies.
  • Create, route, and submit projects and submission materials for review.
  • Build PDF review documents using SOPs and maintain functional and reference annotations.
  • Maintain files, records, and shared-server organization for all stages of review.
  • Monitor submission mailboxes, download comment files, file approvals, and distribute paths to the team.
  • Open MLR job codes and upload or submit new reference materials and review packages across client platforms.
  • Set up, start, monitor, and obtain team approval for submission review routes.
  • Prepare OPDP binders and support archiving and digital asset upload processes.
  • Update project dashboards and shared tracking spreadsheets with submission dates and status.
  • Attend brand meetings, internal meetings, and project kickoffs to review workload and timelines.
  • Recommend process improvements to submission formats, layouts, and overall efficiency.

Requirements

  • Highly deadline-driven and able to manage fast-moving submission cycles.
  • Adaptable and flexible when priorities, timelines, or client needs shift.
  • Strong multitasking ability to balance concurrent projects with accuracy and quality.
  • Detail-oriented with a focus on consistency, compliance, and completeness.
  • Proactive communicator who can keep teams informed and anticipate roadblocks.
  • Organized and process-minded with strong workflow and documentation management.
  • Comfortable working across multiple systems and platforms and learning new tools quickly.
  • Collaborative team player who can also work independently and take ownership of tasks.
  • Solutions-oriented mindset with an interest in improving processes and efficiency.
  • Ability to remain calm and focused under pressure during tight deadlines.
  • Experience with regulatory operations, submissions, or MLR workflows is preferred.

Benefits

  • Fully remote work environment.
  • Company-paid medical and dental coverage.
  • 401(k) benefit.
  • Tuition reimbursement.
  • Flexible time off.
  • Competitive base salary of $58,000-$65,000 USD.
  • Flexible benefits, personal support, and tailored learning and development opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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