Head of Medical Information (Director/Senior Director) – Medical Affairs
Vor Bio
7 hours ago
Remote friendly (Boston, MA)
United States
Medical Affairs
Head of Medical Information (MI)
Location: Boston, MA preferred
Role & Responsibilities:
- Lead end-to-end buildout of the MI function (team, technology, content, SOPs, vendor ecosystem) aligned with launch readiness.
- Develop and execute global MI strategy aligned with company objectives and regulatory standards.
- Establish MI operational infrastructure (inbound channels, escalation pathways, response turnaround standards, documentation requirements) prior to US launch.
- Ensure global compliance with regulatory requirements and company policies; integrate with pharmacovigilance safety database, medical CRM, and document management system.
- Develop, implement, and maintain MI governance documents (SOPs/policies/WIs).
- Oversee Standard Response Documents (SRDs) library and content governance; ensure scientifically accurate, balanced, up-to-date SRDs and FAQs.
- Drive implementation/optimization of emerging technologies.
- Lead, mentor, and develop the MI team; foster scientific excellence, compliance rigor, and continuous improvement.
- Establish/maintain MI quality assurance program; ensure data management complies with applicable data protection regulations.
- Serve as primary MI representative in cross-functional launch readiness governance; provide MI performance reporting to MA leadership.
- Partner with Pharmacovigilance, Regulatory Affairs, Commercial, and IT to support launches and lifecycle management.
- Monitor/analyze medical inquiry trends; develop KPIs to track MI performance, quality, and compliance.
Qualifications:
- Advanced degree (PhD, MD, PharmD, or equivalent) required.
- Director: 10 years MI/MA in pharma/biotech; 3+ years management/leadership.
- Senior Director: 12+ years MI/MA; 3+ years management/leadership.
Skills/Competencies (Required/Preferred):
- Deep knowledge of US regulatory frameworks for medical information.
- Scientific acumen for global MI leadership in autoimmune space.
- Strong project management; cross-functional leadership and stakeholder management.
- Proficiency with inquiry tracking systems, document platforms, and reporting tools (Power BI, Tableau, Excel).
- Excellent scientific written/verbal communication; executive presentation experience.
- Key attributes: proactive, growth mindset, humility, excellence, high emotional intelligence.
- Preferred: ex-US regulatory familiarity, multi-country MI operations.
- Highly desirable: immunology/autoimmune/rare disease experience; MI launch leadership; experience managing outsourced MI operations; outsourced inquiry management platforms; scientific/clinical data review.
Benefits (explicitly stated):
- Comprehensive health coverage, flexible paid time off, generous parental leave, competitive 401(k), education assistance, wellness resources, financial security.
Location: Boston, MA preferred
Role & Responsibilities:
- Lead end-to-end buildout of the MI function (team, technology, content, SOPs, vendor ecosystem) aligned with launch readiness.
- Develop and execute global MI strategy aligned with company objectives and regulatory standards.
- Establish MI operational infrastructure (inbound channels, escalation pathways, response turnaround standards, documentation requirements) prior to US launch.
- Ensure global compliance with regulatory requirements and company policies; integrate with pharmacovigilance safety database, medical CRM, and document management system.
- Develop, implement, and maintain MI governance documents (SOPs/policies/WIs).
- Oversee Standard Response Documents (SRDs) library and content governance; ensure scientifically accurate, balanced, up-to-date SRDs and FAQs.
- Drive implementation/optimization of emerging technologies.
- Lead, mentor, and develop the MI team; foster scientific excellence, compliance rigor, and continuous improvement.
- Establish/maintain MI quality assurance program; ensure data management complies with applicable data protection regulations.
- Serve as primary MI representative in cross-functional launch readiness governance; provide MI performance reporting to MA leadership.
- Partner with Pharmacovigilance, Regulatory Affairs, Commercial, and IT to support launches and lifecycle management.
- Monitor/analyze medical inquiry trends; develop KPIs to track MI performance, quality, and compliance.
Qualifications:
- Advanced degree (PhD, MD, PharmD, or equivalent) required.
- Director: 10 years MI/MA in pharma/biotech; 3+ years management/leadership.
- Senior Director: 12+ years MI/MA; 3+ years management/leadership.
Skills/Competencies (Required/Preferred):
- Deep knowledge of US regulatory frameworks for medical information.
- Scientific acumen for global MI leadership in autoimmune space.
- Strong project management; cross-functional leadership and stakeholder management.
- Proficiency with inquiry tracking systems, document platforms, and reporting tools (Power BI, Tableau, Excel).
- Excellent scientific written/verbal communication; executive presentation experience.
- Key attributes: proactive, growth mindset, humility, excellence, high emotional intelligence.
- Preferred: ex-US regulatory familiarity, multi-country MI operations.
- Highly desirable: immunology/autoimmune/rare disease experience; MI launch leadership; experience managing outsourced MI operations; outsourced inquiry management platforms; scientific/clinical data review.
Benefits (explicitly stated):
- Comprehensive health coverage, flexible paid time off, generous parental leave, competitive 401(k), education assistance, wellness resources, financial security.