Medical, Legal and Regulatory Coordinator

This is a fully remote position, open to applicants in Kansas.

📋 Description

• Oversees the comprehensive MLR process from start to finish.

• Responsible for organizing, setting the agenda, and facilitating Review Committee meetings.

• Adds real-time discussion notes for comments addressed during Veeva Vault Scribe meeting minutes.

• Ensures that all communications are thoroughly vetted through the review process using the online review system.

• Rejects submissions that are incomplete or materials that are not ready for review.

• Assists with FDA 2253 submissions or country-specific regulatory submissions alongside MLR Regulatory Reviewer/Partner.

• Aids in the creation of project plans.

• Supports the medical content development team.

• Collaborates with Medical Affairs and Medical Information leadership to develop and manage project plans for key initiatives.

⛳️ Requirements

• Graduates in any Life Sciences or Biomedical field.

• Must exhibit exceptional communication skills in English, both spoken and written.

• Minimum of 2 years of experience in a healthcare agency or pharmaceutical company.

• Familiarity with Veeva Vault PromoMats and MedComms.

• Experience in Scientific Writing, Scientific Reviewing, and MLR Project Management.

• Proficient in Outlook and the Microsoft Office Suite (Word, Excel, PowerPoint, and other Windows applications).

🏝️ Benefits

• Medical coverage.

• Legal and Regulatory (MLR) Coordinator role.

• Contract position.

• Flexible work arrangements.