Senior MLR Specialist

Overview

This role supports end-to-end MLR (medical/legal/regulatory) document review for a neuromuscular program area, including administration of the document management system and ensuring compliance with internal policies and external regulations.

Responsibilities

• Own the day-to-day administration and execution of designated MLR processes while supporting development and implementation of the MLR process, procedures, and related SOPs and work practices; identify and drive process improvement opportunities.
• Serve as a business administrator for the document management platform used for promotional materials and medical communications; lead configuration and implementation, and build reports to track review activity and inform process improvements.
• Act as the primary point of contact for scheduling and facilitating MLR meetings, capturing comments, driving issue resolution, and keeping projects on schedule against established timelines.
• Prepare and scribe clear meeting minutes, decision logs, and action items; circulate them for approval and file the approved record.
• Perform quality control on submitted materials, including verification of final documents against the approved version.
• Gather and maintain a forward-looking submission forecast with brand and medical sponsors, and translate it into review capacity planning.
• Support or oversee preparation and filing of regulatory agency submissions where applicable (such as FDA Form 2253).
• Serve as a primary resource for internal stakeholders and agency partners on MLR processes, delivering training and day-to-day guidance on best practices for compliant content creation, submission requirements, and system workflows.

Requirements

• Minimum bachelor’s degree in a life science, communications, or related field.
• Minimum of 5-7 years in pharmaceutical, biotechnology, or medical device, with at least 3 to 4 years of direct exposure to promotional review, regulatory affairs, medical affairs, or commercial operations.
• Experience with Veeva or a comparable electronic document and promotional review management system.
• Working knowledge of FDA OPDP expectations for promotional materials, including fair balance, substantiation, and use of references.
• Strong written communication, including the ability to prepare meeting minutes, decisions, and action items that others can understand and act on.
• Demonstrated ownership of recurring, deadline-driven, cross-functional meetings, with proven ability to manage multiple priorities and hold timelines.
• Highly organized and quality-oriented with consistent attention to detail; follows established procedures while adapting to new practices and shifting priorities.
• Experience supporting the review of promotional and medical materials, including document control, records retention, and audit readiness.
• Sound judgment and discretion when handling confidential, regulated, and commercially sensitive information.

Preferred Qualifications

• Direct experience with Veeva PromoMats or Veeva Vault.
• Prior MLR, PRC, or MRC coordinator/specialist experience.
• Product launch experience.
• Familiarity with agency workflows and creative production timelines.

Compensation & Benefits

• Salary: $115,000—$140,000 USD
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take-what-you-need” paid time off and company-paid holidays
• Comprehensive paid medical and parental leave

Location

U.S.-based remote role requiring quarterly, or as-needed, visits to the San Francisco office.

Salary note: This anticipated salary range applies to candidates for this role who will work in California. The final salary offered may depend on factors including type and length of experience within the job and industry, educational background, location of residence, and performance during the interview process. The employer is multi-state, and the salary range may not reflect positions based in other states.