MLR Reviewer - Avance Consulting : Job Details

Job Title: MLR Reviewer

Location: Wilmington, DE

Work Setup: Onsite one day per week; remote work for the remaining four days.

Contract: 6+ Months

Core Responsibilities:

1. Content Review and Compliance:

Perform detailed Medical, Legal, and Regulatory (MLR) reviews of advertising, promotional, and non-promotional materials.

Ensure all materials comply with US FDA regulations, industry standards, and company policies.

Validate content for scientific accuracy, claim substantiation, and clinical evidence.

2. Expertise in Regulations and Guidelines:

Provide regulatory review expertise, focusing on fair balance, benefit-risk communication, and alignment with US FDA advertising and promotional regulations.

Ensure compliance with standards for both medicinal products and medical devices.

3. Hands-On Tools and Workflow Development:

Use lifecycle management (LCM) tools such as Veeva Vault PromoMats and Vault

MedComms for content management and approvals.

Develop checklists, templates, and workflows to streamline the MLR review process.

4. Collaboration and Communication:

Collaborate with cross-functional teams such as Marketing and Medical Affairs to address compliance issues and facilitate the review and approval process.

5. Content and Documentation Review:

Review diverse materials, including HCP presentations, social media content, websites, advertisements, brochures, and press releases.

Assess clinical documentation such as product labels, prescribing information (PI), and patient leaflets for accuracy and compliance.

6. Knowledge Development:

I'd like for you to maintain an in-depth understanding of therapeutic areas, trial designs, disease states, and product-related information to enhance the review process.

Required Skills and Experience:

Specialized Experience:

8–10 years of experience in MLR review processes, strongly focusing on US FDA regulations for medicinal products and medical devices.

Proficiency in lifecycle management tools (e.g., Veeva Vault PromoMats).

Knowledge Areas:

Comprehensive understanding of US advertising and promotional regulations.

Familiarity with PRC/MRC structures and processes.

Solid background in clinical documentation and regulatory requirements for medicinal products and medical devices.

Communication and Process Improvement:

Ability to collaborate effectively with cross-functional teams.

Experience in developing best practices for consistent MLR reviews across projects.

Regulatory Compliance Expertise:

Sound knowledge of FDA regulatory guidance, fair balance, benefit-risk communication, and industry codes of practice.