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Reporting to the Senior Medical Director of US Medical Affairs, the Director of Medical Information will be an integral team member of the US Medical Affairs team at Alfasigma. The Director of Medical Information leads and owns the Medical Information function, providing strategic, operational, and organizational leadership across all medical information activities. This role is responsible for establishing the vision, structure, and standards for the function, ensuring the consistent delivery of high quality, accurate, and compliant scientific communications to healthcare professionals, patients, and internal stakeholders.
Job Responsibility:
Lead and oversee the end-to-end Medical Information function, including strategy, operations, systems, and performance across all products within GI and hepatology
Develop and maintain high quality, compliant scientific content, including standard response documents, FAQs, and AMCP dossiers aligned with GI and liver disease data
Direct medical inquiry management and lead/manage call center operations, ensuring timely, accurate, and balanced responses to healthcare professionals, patients, and internal stakeholders
Oversee medical information systems and infrastructure, including knowledge management systems and content repositories to ensure efficiency, scalability, and compliance
Serve as the subject matter lead for GI and hepatology medical information, ensuring deep understanding of disease state, clinical data, and evolving treatment landscape
Ensure all medical information activities are aligned with regulatory, legal, quality, and pharmacovigilance requirements, including adverse event reporting and product safety processes
Lead compendia strategy and submissions, including development and maintenance of clinical and pharmacoeconomic content for inclusion in key drug compendia
Partner cross-functionally with Medical Affairs, Clinical Development, Regulatory, Legal, and Commercial teams to support product launches, lifecycle management, and scientific exchange
Generate and synthesize insights from medical inquiries and call center interactions to inform medical strategy, evidence generation, and field engagement plans
Support GI and hepatology product launches by developing core medical information materials, training content, and response strategies
Oversee vendor management and external partners, including call center providers and content vendors, ensuring quality, compliance, and scalability
Establish and track key performance indicators to continuously improve medical information quality, responsiveness, and stakeholder experience
Lead medical booth operations at scientific congresses, including development of booth and materials, training of staff, and management of on-site medical information activities
Train and mentor internal teams on medical information processes, systems, scientific communication standards, and GI and hepatology specific knowledge
Ensure inspection readiness and maintain documentation standards to support audits and regulatory reviews
Requirements:
Healthcare professional (MD, PharmD/RPh, or other relevant degree)
6-8 years of progressive medical information experience, including leading several functions within Medical Information
product launch experience highly preferred
Strong understanding of Medical Information responsibilities and operational processes
AMCP Dossier experience
20% travel will be required to US and Global medical/scientific congresses, including overnight and weekend travel
Excellent written, oral, and presentation skills and demonstrated ability to critically analyze scientific literature to develop materials for communication
Strong teamwork and interaction skills to be able to interface effectively with internal and external partners, including vendors