Senior MLR Specialist

Reporting to the Associate Director, Medical Affairs, the Sr MLR Specialist manages the end-to-end MLR review process for BridgeBio Neuromuscular. The Sr MLR Specialist serves as subject matter expert for the document management system that supports MLR review and ensures that administrative and program management support for MLR operates effectively and in full compliance with internal policies and external regulations.

The ideal candidate has strong planning, prioritization, organization and follow-through, along with executive functioning, negotiating skills, and the confidence to hold senior stakeholders accountable to established timelines. They keep a high-volume review process moving across Medical, Legal, Regulatory, and Commercial without sacrificing documentation quality.

• →Owns the day-to-day administration and execution of designated MLR processes while supporting the development and implementation of the MLR process, procedures, and related SOPs and work practices – identifies and drives areas for process improvement.
• →Serves as a business administrator for the document management platform (Veeva PromoMats and MedComms) – leads configuration and implementation, and builds reports to track review activity and inform process improvements
• →Serves as primary point of contact for scheduling and facilitating MLR meetings, including capturing comments, driving issue resolution, and keeping projects on schedule against established timelines
• →Prepares and scribes clear meeting minutes, decision logs and action items; circulates them for approval, and files the approved record
• →Performs quality control on submitted materials, including verification of final documents against the approved version
• →Gathers and maintains the forward-looking submission forecast with brand and medical sponsors, and translates it into review capacity planning
• →Support or oversee preparation and filing of regulatory agency submissions (such as FDA Form 2253) where applicable.
• →Serves as the 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.

• 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 — specifically, the ability to prepare meeting minutes, decisions, and action items that someone who was not in the room 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

• 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