Senior Medical Information Specialist

Role Summary

The Senior Medical Information Specialist is responsible for meeting the medical information needs of internal and external Tonix stakeholders related to the company's investigational and marketed products. This role ensures the accurate, timely, and compliant dissemination of scientific and medical information in accordance with FDA guidance and internal policies. The incumbent will contribute to the development and maintenance of high-quality Medical Information deliverables and will serve as a visible and collaborative member of the Medical Affairs organization, partnering cross-functionally to support Medical Affairs objectives and strategic priorities.

Responsibilities

• Medical Information Content Development: Develops, reviews, and maintains a comprehensive library of standard medical response documents, including Standard Response Letters (SRLs) and Frequently Asked Questions (FAQs), to support consistent and compliant responses to medical inquiries from healthcare professionals, payers, and consumers.
• Ensures all medical information content is scientifically accurate, balanced, current, and aligned with FDA regulations, product labeling, and internal review processes.
• Updates medical response documents proactively as new clinical, safety, or publication data become available.

• Inquiry Management & Contact Center Support: Provides direction, training, and ongoing guidance to external Medical Information Contact Center staff on the handling of unsolicited medical inquiries, including appropriate escalation pathways and documentation standards.
• Reviews and approves inquiry responses generated by external vendors and develops customized responses for complex, high-impact, or escalated inquiries as needed.
• Ensures consistent application of scientific exchange principles and compliance with FDA guidance on off-label and unsolicited requests.

• Scientific Exchange & Congress Support: Provides medical information support at medical and scientific congresses, including booth coverage, scientific response support, and post-congress inquiry follow-up as required.
• Collaborates with Medical Affairs colleagues to ensure alignment between Medical Information content and broader scientific communication strategies.

• Literature Surveillance & Internal Communication: Conducts ongoing literature surveillance and provides timely publication alerts and summaries to internal stakeholders, highlighting business-, clinical-, or development-relevant data.
• Supports internal education by responding to medical information requests from field medical, commercial, and other cross-functional partners, as appropriate and compliant.

• Metrics, Reporting & Continuous Improvement: Contributes to Medical Information inquiry metrics and periodic reports, including analysis of inquiry volume, trends, frequently requested topics, and emerging data gaps.
• Identifies opportunities to enhance Medical Information processes, content, and systems to improve efficiency, quality, and stakeholder satisfaction.

• Cross-Functional Collaboration: Collaborates closely with Clinical Development, Pharmacovigilance, Regulatory Affairs, Commercial, Legal, and Field Medical teams to ensure alignment and consistency of medical information across the organization.
• Participates in departmental initiatives and projects in support of Medical Affairs objectives.

Qualifications

• Up to 2 years of direct Medical Information experience within the pharmaceutical, biotechnology, or healthcare industry.

Skills

• Strong understanding of FDA guidance documents and regulations governing medical information and appropriate scientific exchange.
• Demonstrated experience in medical writing, including the ability to clearly and concisely communicate complex scientific and clinical data to diverse audiences.
• Excellent analytical, organizational, and communication skills, with strong attention to detail.
• Ability to work independently while effectively collaborating in a cross-functional team environment.
• Experience with Medical Information systems and document management platforms; experience with Veeva Vault strongly preferred.
• Ability to travel up to 15%

Education

• RPh, RN, or PharmD required.

Additional Requirements

• Travel up to 15%