Director, Medical Information
Ultragenyx
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $210,500 - $260,000 per year
Job Level
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical information strategyscientific reviewinquiry managementmedical reviewregulatory compliancequality management processesperformance standardsevidence-based responsesscientific communicationspipeline programs
Soft Skills
leadershipstrategic directioncollaborationcommunicationoversightproblem-solvingorganizational skillsattention to detailadaptabilitycross-functional teamwork
Certifications
PharmDPhDMD