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Ultragenyx Pharmaceutical, founded in 2010, is a biotechnology company that specializes in bringing products to market to treat rare, ultra-rare, and serious ge
Director, Medical Information
Location
United States
Posted
95 days ago
Salary
$210.5K - $260K / year
Seniority
Lead
Job Description
Director, Medical Information
Ultragenyx Pharmaceutical
• Lead the global medical information strategy and operations, ensuring compliant, evidence based responses to unsolicited inquiries from HCPs, patients, and internal teams. • Oversee creation, review, and maintenance of global standard response letters, FAQs, and medical information resources across marketed and pipeline programs. • Ensure all materials remain scientifically current, aligned with evolving data, and consistent with regulatory expectations globally. • Provide strategic direction and quality oversight for outsourced medical information contact center operations. • Define performance standards, service metrics, and quality management processes for vendor partners. • Ensure clear triage pathways and timely escalation of complex scientific inquiries to internal experts. • Monitor inquiry trends to identify emerging knowledge gaps, safety issues, or reputational risks. • Maintain inspection readiness for all medical information systems, processes, and documentation. • Serve as Medical reviewer within the Medical–Legal–Regulatory process for assigned assets. • Provide scientific review of medical information materials, HCP resources, training content, and other scientific communications. • Ensure all externally facing materials are accurate, balanced, and aligned with current evidence and regulatory guidance. • Guide the appropriate handling of off label and unsolicited scientific inquiries. • Govern the scientific accuracy and consistency of all medical information content. • Partner with Medical Affairs subject matter experts to ensure response materials reflect the company’s scientific narrative. • Align medical information with publications, field medical materials, and medical education strategies. • Maintain and govern the MI scientific response library supporting global field medical consistency. • Represent Medical Information on cross functional product teams for marketed and pipeline assets. • Collaborate with Pharmacovigilance on identification and triage of safety related information. • Work closely with Regulatory, Legal, and Compliance to ensure adherence to global guidelines governing scientific exchange. • Partner with Scientific Communications to ensure coherent scientific messaging across channels.
Job Requirements
- Advanced degree in life sciences, pharmacy, or medicine (PharmD, PhD, MD, or equivalent), with rare disease experience strongly preferred.
- 10+ years of experience in pharmaceutical or biotechnology industry roles, including at least 7 years of experience in Medical Information.
- Demonstrated experience leading or managing a Medical Information function or major Medical Information program, including oversight of inquiry management processes and scientific response content.
- Experience with medical information databases and inquiry management systems.
- Experience supporting medical review of scientific materials within an MRC process.
- Experience overseeing outsourced Medical Information contact center vendors strongly preferred.
- Experience working cross-functionally with Regulatory, Pharmacovigilance, Legal, and Commercial teams.
- Strong understanding of regulatory requirements governing medical information and scientific exchange.
- Excellent written and verbal scientific communication skills.
- Experience supporting product launches and pipeline programs.
Benefits
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
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