Job Title: MLR AI Product Specialist
Applicants must be U.S. citizens, lawful permanent residents (Green Card holders), or individuals with authorization to work in the United States. This position is not open to individuals requiring sponsorship for employment visas now or in the future.
Company Overview:
We are an innovative AI company transforming the Medical, Legal, and Regulatory (MLR) review process for the pharmaceutical industry. Leveraging cutting-edge technology, we automate and enhance content review, compliance management, and strategic alignment of promotional materials, streamlining workflows to drive faster, more accurate regulatory submissions.
Role Overview: We're looking for an innovative, forward-thinking MLR reviewer eager to revolutionize regulatory review processes through advanced technology. As an MLR AI Product Specialist, you'll leverage your experience to reimagine the MLR review process, driving product innovation and refining AI-driven workflows. This role offers an opportunity to shape the future of pharmaceutical compliance by integrating your expertise directly into groundbreaking technology solutions.
Key Responsibilities:
· Serve as the MLR subject-matter expert influencing product development, functionality, and workflow design.
· Conduct quality control and validation of AI-generated outputs, ensuring they meet industry compliance and medical accuracy standards.
· Collaborate closely with Product, Engineering, and Data Science teams to refine product features and enhance AI capabilities.
· Lead internal efforts to define key workflow processes, standardize best practices, and establish product-specific guidelines.
· Participate in select client meetings, providing demonstrations, gathering feedback, and offering strategic product insights.
· Monitor regulatory trends and FDA guidance updates, proactively integrating these insights into product evolution.
· Conduct training and knowledge transfer internally and externally, positioning the product clearly within the MLR review process.
Requirements:
· Mid-level experience as an MLR reviewer at a Top 20 pharmaceutical company.
· Demonstrated expertise in FDA regulatory requirements and promotional content compliance.
· Proven experience reviewing and approving promotional materials across various therapeutic areas.
· Previous hands-on experience with Veeva systems (PromoMats).
· Exceptional analytical, organizational, and communication skills.
· Ability and willingness to engage in client-facing activities.
Preferred Qualifications:
· Experience implementing new technology products internally within a pharmaceutical company.
· Strong understanding of MLR review processes and strategic compliance frameworks.
Additional Qualifications:
· Excellent presentation and interpersonal skills for client-facing activities.
· Proactive approach to identifying regulatory trends and implications for product innovation.
Why Join Us:
· Opportunity to shape innovative products transforming pharmaceutical compliance.
· A collaborative and agile work environment emphasizing professional growth and impact.
· Competitive compensation, comprehensive benefits, and professional development opportunities.
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