Senior Medical Information Specialist
Listed on 2025-12-20
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Healthcare
Medical Science, Clinical Research
Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first‑in‑class, once‑daily, non‑opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement.
Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® Sym Touch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults.
Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno‑oncology, infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases.
Finally, rare disease portfolio includes a product in development for Prader‑Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA.
Tonix owns and operates a state‑of‑the‑art infectious disease research facility in Frederick, Md.
Please visit for specifics on the pipeline.
* All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
Position OverviewThe 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.
MedicalInformation 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.
- 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.
- 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.
- Conducts ongoing literature…
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