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Tonix Pharmaceuticals · 4 weeks ago

Senior Medical Information Specialist

Berkeley Heights, NJ

Full-time

Onsite

Mid, Senior Level

0+ years exp

Tonix Pharmaceuticals is a fully integrated biotechnology company focused on commercializing and developing therapeutics to treat and prevent human diseases. The Senior Medical Information Specialist will be responsible for meeting the medical information needs of stakeholders related to investigational and marketed products, ensuring compliant dissemination of scientific information and contributing to high-quality Medical Information deliverables.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

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 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

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

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

Qualification

FDA guidance knowledgeMedical writing experienceMedical Information systemsData visualization toolsPharmaceutical/Biotech experienceAnalytical skillsOrganizational skillsCommunication skillsAttention to detailCross-functional collaboration

Required

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%

RPh, RN, or PharmD required

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