Qureos Mentor

Neurelis

<div>Description:

Job Summary/Objective:
The Director, Medical Information, supports Neurelis&rsquo; Medical Information function by leading the development and maintenance of core medical content (e.g., FAQs, slide decks, standard response letters), providing product and disease-state training to internal stakeholders and vendors, and serving as a subject matter expert for internal and external audiences. The role reviews and approves medical materials that are scientifically accurate and clinically relevant through the Medical/Legal/Regulatory (MLR) compliance process. They will support Publication Response Team activities, provide scientific presentations and evidence-based responses to payors in support of Market Access, and contribute to cross-functional Medical Affairs initiatives. The Director will apply scientific expertise to address escalated product and disease-state inquiries, develop quarterly internal newsletters, maintain AMCP dossier updates, and provide scientific input on company products (including VALTOCO), investigational therapies, and corporate partner activities.
Essential Job Functions:<ul><li>
Serve as Medical reviewer for promotional and non-promotional materials through Medical, Legal, and Regulatory (MLR) review processes, including manuscripts, abstracts, posters, slide presentations, and other Medical Affairs deliverables, ensuring scientific accuracy, clinical relevance, and compliance with company policies and applicable regulations.</li><li>
Support the development, maintenance, and lifecycle management of Medical Information content, including standard response documents, FAQs, scientific slide decks, AMCP dossier content, publication summaries, and other medical communication resources.</li><li>
Contribute to Medical Information process improvements, operational initiatives, and inspection readiness activities.</li><li>
Support Medical Affairs activities at scientific congresses and professional meetings, including booth coverage, scientific discussions, review of congress materials, and cross-functional collaboration.</li><li>
Support the development and interpretation of Medical Information metrics, trend analyses, and reporting activities to inform operational planning and continuous improvement.</li><li>
Support vendor training activities and contribute to the oversight of Medical Information quality and operational performance.</li><li>
Oversee content creation in the development and maintenance of FAQ documents, standard response letters, and other key Medical Information deliverables.</li><li>
Serve as a subject matter expert in the periodic product/disease state training of vendors as well as internal colleagues and external customers as requested.</li><li>
As needed, provide compliant support for Market Access colleagues in the presentation of scientific data to payors.</li><li>
Support the handling of unsolicited escalated medical inquiries, periodic Medical Information reports, and future updates to the AMCP Dossier.</li><li>
Help ensure compliance with regulatory guidelines, processes and procedures in preparation for audits and inspections.</li><li>
Assist in the creation and maintenance of Neurelis Medical Information-related SOPs, work instructions and business practices.</li><li>
Participate as a subject matter expert during internal audits and assist Regulatory, Quality, Drug Safety and other teams during Agency inspection activities as required.</li><li>
May provide project leadership, training, and guidance to vendors, contractors, and cross-functional stakeholders, as appropriate.</li></ul>
Competency (Knowledge, Skills, and Abilities):<ul><li>
Experience participating in Medical, Legal, and Regulatory (MLR) review processes for promotional and non-promotional materials.</li><li>
Strong knowledge of Medical Information content development and scientific communications.</li><li>
Strong analytical skills with the ability to interpret Medical Information metrics, identify trends, and communicate actionable insights.</li><li>
Ability to manage multiple competing priorities in a fast-paced, matrixed environment.</li><li>
Strong project management and organizational skills.</li><li>
Knowledge of applicable regulations regarding dissemination of medical information, development of promotional and non-promotional materials, and AE/PC reporting is highly preferred.</li><li>
Corporate experience in the CNS therapeutic area is preferred.</li><li>
Knowledge of platforms, systems and processes commonly used to support Medical Information operations.</li><li>
Functional awareness of customer segments within neurology, particularly that of epilepsy and/or rescue medications.</li><li>
Exceptional communication and organizational skills.</li></ul>
Personal Performance Factors:<ul><li>
Demonstrates strong work ethic.</li><li>
Shows initiative and holds themselves accountable.</li><li>
Lives and advances the Neurelis culture and values.</li><li>
Always operates with a high degree of integrity and tact.</li><li>
Demonstrates sound judgment and decision-making ability.</li></ul>
Management Responsibilities and Skills:<ul><li>
This position has no direct reports.</li></ul>
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Spends approximately 90% of work time sitting and meeting with others or working at a desk and/or computer. Spends approximately 10% of work time standing or walking within the work area or at meetings and bends, twists, stoops and reaches. Ability to communicate verbally and in writing. Occasionally lifts and/or moves up to 10 pounds. Working conditions are normal for an office environment. The noise level is usually moderate.
Travel Requirements:<ul><li>
Ability to travel up to 10% within the United States.</li></ul>
Requirements:

Minimum Education and Experience Required:<ul><li>
Advanced degree in life sciences (PharmD, PhD, MD, NP); 6+ years of experience in the industry, with the majority spent within Medical Affairs.</li><li>
Experience serving as a Medical reviewer within Medical, Legal, and Regulatory (MLR) review process.</li><li>
Working knowledge of Medical Information creation and delivery, including the ability to evaluate information from multiple sources.</li><li>
Experience in conducting literature searches, evaluating literature, and applying drug information concepts.</li><li>
Knowledge and understanding of medical terminology, drug names/classes, clinical and pharmaceutical aspects of medicines.</li><li>
Strong analytical and problem-solving skills.</li></ul>
Preferred Education and Experience:<ul><li>
Experience developing and utilizing Medical Information metrics, vendor performance indicators, inquiry trend analyses, and workload assessments to support operational planning and resource allocation.</li><li>
Experience evaluating and implementing emerging technologies, including AI-enabled tools, to enhance Medical Information operations, analytics, content development, and workflow efficiency.</li><li>
Experience with review and utilization of HEOR data in medical materials.</li></ul></div>

Director, Medical Information

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Director, Medical Information