Legal Manager – Commercial & PMRC

The role

This attorney will serve as a legal resource for promotional review and commercial activities. You will partner with cross-functional stakeholders to support compliant product promotion and commercialization.

What you will do

• Serve as a primary legal reviewer in the PMRC/MLR process.
• Review U.S. and global promotional and non-promotional materials.
• Advise on legal and compliance requirements for pharmaceutical advertising and activities.
• Partner with stakeholders to advise on compliant commercial strategies and brand plans.
• Oversee and improve the PMRC/MLR review process and workflows.
• Identify and assess legal and compliance risks relating to products and commercial activities.
• Draft, review, and negotiate commercial agreements.
• Provide legal support on other commercial, compliance, and cross-functional matters.

Required qualifications

• LL.B. / LL.M. from a recognized college or university
• Approximately 5+ years of post-qualification legal experience
• At least 2+ years of experience supporting pharmaceutical promotional/MLR review for products marketed in the U.S.
• Demonstrated experience reviewing pharmaceutical promotional and non-promotional materials
• Strong working knowledge of U.S. pharmaceutical laws, regulations, and industry requirements, including the Anti-Kickback Statute, False Claims Act, HIPAA, and Sunshine Act
• Familiarity with FDA requirements and principles governing prescription drug advertising and promotion
• Excellent written and verbal communication skills

Nice to have

• Experience with or knowledge of global pharmaceutical advertising and promotional requirements
• Experience with Vodori or a similar pharmaceutical promotional review and approval platform
• Experience supporting innovator and/or 505(b)(2) pharmaceutical products

Before you apply

• By applying, you confirm you are mentally and physically capable of fulfilling the job responsibilities without any restrictions.

About the company

Azurity Pharmaceuticals is an inclusive workplace and an Equal Opportunity Employer. The company focuses on repurposing proven molecules and reimagining how therapies are designed, delivered, and accessed.