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Ultragenyx

Rare mission. Fearless team. Incredible possibilities.

Director, Medical Information

DirectorDirectorFull TimeRemoteLeadTeam 501-1,000Since 2010H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

4 days ago

Salary

$210.5K - $260K / year

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

• 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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