Overview
This role owns the strategy, governance, and end-to-end operation of the Medical, Legal, Regulatory (MLR) review process for promotional, medical, training, and other regulated materials. The Director, MLR Operations ensures materials move through review and approval accurately, compliantly, and on time.
In addition to executing the process, this position serves as the strategic owner of the MLR operating model—designing scalable workflows, setting governance standards, and advising senior Medical, Legal, Regulatory, and Commercial leadership. Success requires the ability to hold senior stakeholders accountable, balance speed with review capacity and process requirements, and ensure compliance risks are escalated to the appropriate decision makers.
Medical, Legal, Regulatory, and Compliance functions retain accountability for their substantive review decisions, while this role is accountable for the effectiveness, integrity, and operational performance of the MLR process.
Responsibilities
Strategic Process Ownership
- Own the MLR operating model end-to-end, including intake, routing, review cycles, approvals, and archiving, and continuously evolve the model as volume, therapeutic areas, and regulatory expectations change
- Set governance standards, SOPs, and best practices for the review process, ensuring consistent adoption across Medical, Legal, Regulatory, and Marketing
- Serve as business owner for the technology ecosystem (e.g., Veeva Vault PromoMats), partnering with IT and Compliance on configuration, upgrades, and process automation opportunities
- Identify systemic bottlenecks and lead cross-functional process improvement initiatives using data to justify changes to senior stakeholders
Planning, Prioritization & Delivery
- Build and maintain enterprise-wide review calendars across teams, launches, and material types (promotional, training, medical, and other)
- Lead MLR operational readiness for new product launches, indications, label changes, and other high-volume business events, including submission volume forecasting, reviewer capacity planning, critical path calendars, and escalation protocols
Cross-Functional Leadership & Influence
- Act as the primary strategic point of coordination between Medical, Legal, Regulatory, Marketing, and Commercial leadership on all review matters
- Facilitate and, when needed, redesign MLR review governance meetings to drive efficient, decisive outcomes among senior reviewers
- Establish and reinforce clear roles, service-level expectations, timelines, and escalation protocols across reviewer functions and organizational levels; constructively address deviations that put quality, compliance, or business timelines at risk
- Build credibility and trusted-advisor relationships across the matrix, influencing decisions and behavior change without direct authority
- Proactively escalate risks to timelines or compliance with clear, data-backed rationale and recommended solutions
- Provide role-based training and onboarding for material owners, reviewers, agencies, and other stakeholders
- Establish submission and approval requirements for external agencies and partners
Reporting, Compliance & Continuous Improvement
- Define and maintain an MLR performance framework including submission volume, cycle time, SLA adherence, review rounds, aging, and more; translate insights into capacity plans, process improvements, and leadership recommendations
- Ensure audit- and inspection readiness through accurate, well-governed review documentation and records retention
- Stay current on evolving FDA, OPDP, and PhRMA Code expectations, partnering with Regulatory, Legal, and Compliance to translate evolving guidance, internal policies, and enforcement trends into the MLR process
- May mentor or oversee junior process coordinators supporting the MLR function
Requirements
- Bachelor’s degree required; advanced degree (MBA, MPH, or related) a plus
- 10 years of experience in pharmaceutical/biotech with significant experience in promotional review, MLR/PRC operations, content operations, or a closely related function
- Additional experience in medical affairs, regulatory, legal review, or compliance operations, including experience operating at a strategic or leadership level, is a plus
- Direct, hands-on experience owning or significantly shaping an MLR review process, including platform ownership (e.g., Veeva Vault PromoMats)
- Strong working knowledge of FDA promotional regulations, OPDP guidance, and the PhRMA Code
- Demonstrated success managing complex, multi-stakeholder processes under tight deadlines in a matrixed organization
- Track record of influencing and holding accountable senior leaders (Director level and above) without formal authority
Preferred Qualifications
- Experience in a global, matrixed pharma/biotech organization
- Demonstrated process improvement, project management, or change management capability
- Prior direct experience partnering with Legal and Regulatory review leadership on governance or policy matters
- Experience leading or contributing to MLR platform implementations or major process redesigns
- Demonstrated experience working with small growing companies as they expand their portfolio and scale their business
Compensation & Benefits
- Base compensation range: $210,000 - $225,000
- Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.