Senior MLR Specialist

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'llask"why not?" and help reengineer the future of biopharma. At Bridge Bio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You’ll Do

Reporting to the Associate Director, Medical Affairs, the Sr MLR Specialist manages the end-to-end MLR review process for Bridge Bio 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.

Responsibilities

• 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 Promo Mats and Med Comms) – 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.

Where You’ll Work

This is a U.S.

-based remote role that will require quarterly, or as-needed, visits to our San Francisco office.

Who You Are

• 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…