Medical, Legal and Regulatory Coordinator

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

📋 Description

• Oversees the complete MLR process from start to finish.

• Takes charge of scheduling, setting the agenda, and leading Review Committee meetings.

• Records live discussion notes for comments addressed in Veeva Vault Scribe meeting minutes, circulates draft minutes for Committee approval, and finalizes and archives approved minutes.

• Ensures all communications that require review are thoroughly vetted through the review process using the online review system (e.g., Veeva Vault PromoMats and Vault MedComms).

• Confirms that materials are directed to the correct review path.

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

• Facilitates and documents discussions in live meetings.

• Performs quality checks on Final Documents versus Approved Documents.

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

• Aids in the development of project plans.

• Supports the medical content development team.

• Assists with the upload of materials into clients' review and approval platforms, including tasks such as annotating and anchoring references.

• Aids Medical Affairs and Medical Information leadership in creating and managing project plans for significant initiatives.

⛳️ Requirements

• Degree holders in any Life Sciences or Biomedical field.

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

• Familiarity with Veeva Vault PromoMats / MedComms.

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

• Proficient in time management.

• Skilled in meeting management.

• Exceptional customer service abilities.

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

🏝️ Benefits

• Medical coverage.

• Flexible work arrangements.