Director, Publications – Medical Information

Vaga não está no LinkedIn

🕒 Setembro 26

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $200.000 - $275.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

👻 Score fantasma 0%

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Kardigan

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2023

🏥 Saúde

💼 Consultoria

🎖️ Defesa

Healthcare • Consulting • Defense

Kardigan é uma empresa de saúde cardíaca dedicada a reinventar a medicina cardiovascular. A empresa foca em tornar as doenças cardiovasculares evitáveis e curáveis, desenvolvendo ativamente múltiplos tratamentos direcionados para melhorar os resultados dos pacientes. Kardigan utiliza uma plataforma de pesquisa de ponta e é liderada por uma equipe experiente com profundo conhecimento em desenvolvimento de medicamentos cardiovasculares. Sua missão é inovar e acelerar a criação de medicamentos que abordem diretamente as causas subjacentes das doenças cardiovasculares, fazendo a transição do gerenciamento tradicional de sintomas para curas funcionais.

Descrição

• Co-lead development and execution of integrated publication strategies across all disease areas and development programs. • Drive alignment between publication plans and broader scientific communication objectives. • Manage publication agencies and external publication partners. • Support publication charters and strategic publication plans aligned with clinical development milestones, evidence generation strategies, and Medical Affairs objectives. • Identify publication opportunities across clinical, translational, biomarker, real-world evidence, implementation science, and disease-state education initiatives. • Oversee publication development from concept through submission and dissemination. • Partner with clinical development, biostatistics, regulatory affairs, safety, legal, and research teams throughout publication development. • Lead publication operations infrastructure, including tracking systems, dashboards, annual planning, metrics, budget tracking, and governance workflows. • Ensure adherence to ICMJE guidelines, GPP standards, authorship policies, Sunshine requirements, and publication compliance standards. • Establish inspection-ready documentation, SOPs, work instructions, and quality management processes. • Develop and maintain scientific narratives and communication platforms across disease states. • Ensure consistent scientific messaging across publications, congress activities, medical education, field medical resources, corporate communications, and investor communications. • Lead operational planning, governance, budget management, vendor oversight, and performance reporting across Scientific Communications. • Develop dashboards and KPIs for publication execution, medical information performance, content utilization, and dissemination effectiveness. • Establish scalable systems and technologies for publication management, medical information operations, knowledge management, and launch readiness. • Identify opportunities to leverage AI and digital solutions. • Build and operationalize Kardigan's Medical Information capabilities toward commercialization. • Lead development and maintenance of standard Medical Information response documents, scientific response letters, FAQs, content repositories, and scientific exchange materials. • Establish and improve inquiry intake, triage, escalation, and response processes. • Ensure pharmacovigilance reporting and adverse event identification compliance. • Analyze inquiry trends and generate insights for Medical Strategy, Evidence Generation, and Medical Education priorities. • Serve as a strategic thought partner to Medical Affairs leadership. • Collaborate with Clinical Development, Research, Regulatory Affairs, Field Medical, Patient Advocacy, Commercial Strategy, and External Affairs. • Contribute to integrated Medical Strategy Planning and evidence dissemination planning.

🎯 Requisitos

• PhD, PharmD or equivalent advanced scientific degree. • Demonstrated leadership in publications strategy and execution. • Significant experience managing publication agencies and external vendors. • Strong understanding of publication guidelines, publication ethics, and scientific communications best practices. • Experience leading cross-functional teams in complex development-stage environments. • Exceptional scientific writing, communication, and presentation skills. • 10+ years of pharmaceutical, biotechnology, or medical communications experience preferred. • Cardiovascular disease experience preferred. • Experience supporting launch or pre-launch products preferred. • Medical Information leadership experience preferred. • CMPP certification preferred.