Associate Director, Medical Affairs

UroGen Pharma, Inc.; Princeton (NJ); Hybrid; USD 170,000 - 210,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401k Match

Paid Time Off

Employee Assistance Program

Job summary

UroGen Pharma, Inc. in Princeton, NJ, seeks an Associate Director, Medical Affairs to lead PARC/MRC processes and oversee Medical Information operations.

This role partners with Medical Affairs, Legal, Regulatory, Compliance, and Commercial to deliver timely, accurate, and compliant scientific communications. The position requires terminal degree, experience in medical review, strong communication skills, and ability to travel up to 60%.

Qualifications

• Terminal degree (PhD, PharmD, or another doctorate)
• Experience in medical, legal, and regulatory review processes and/or Medical Information within pharma/biotech
• Excellent oral and written communication, including presentation skills
• Excellent interpersonal skills with ability to manage multiple stakeholder needs
• Demonstrated clinical and scientific expertise, including clinical trials experience
• Ability to travel up to 60%

Responsibilities

• Leads day-to-day coordination of PARC and MRC submissions and reviews for Medical Affairs materials, ensuring alignment with policies and timelines.
• Serves as the primary Medical Affairs point of contact for PARC/MRC operations and partners with Legal, Regulatory, Compliance, Commercial, and others to facilitate timely, high-quality reviews.
• Conducts scientific and medical review of promotional and nonpromotional materials for accuracy, balance, and substantiation.
• Manages submission readiness including intake, reviewer assignment, meeting coordination, status tracking, documentation of decisions, and follow-up on revisions.
• Maintains PARC/MRC records, metrics, SOPs, training materials, and process documentation; identifies opportunities to improve quality and efficiency.
• Provides guidance and training on PARC/MRC requirements to Medical Affairs and cross-functional partners.
• Supports the development, approval, maintenance, and periodic review of Medical Information resources (letters, FAQs, dossiers).
• Triages and responds to unsolicited medical information inquiries with timely, accurate, balanced information.
• Supports Medical Science Liaisons with literature searches and evidence evaluation; escalates complex inquiries as needed.
• Onboards and trains Medical Information staff; contributes to cross-functional training.
• Keeps records, resources, metrics, and procedures up to date; monitors inquiry trends and drives quality improvements.

Job description

About the Company

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers. We are fundamentally changing the way patients are treated for urologic cancers. Watch our New Horizons in Bladder Cancer event and discover why it’s an exciting time to join UroGen® Pharma. Join us and be part of the team that will redefine the future of urological cancer treatment. Behind every UroGen innovation is the inspiration to empower uro-oncology patients with life-changing treatments. At UroGen, our people are our greatest asset. We cultivate a culture built on collaboration, creativity, and continuous growth. UroGen is a dynamic, rapidly expanding organization with an unwavering focus on improving the lives of patients because they deserve better.

Location: Princeton, NJ (Hybrid)

Reporting Manager: Senior Director, Medical Communications

Job Summary

The Associate Director, Medical Affairs supports the development and execution of Medical Affairs strategy through the accurate, timely, and compliant communication and review of scientific, clinical, and technical information. The role is structured as an equal allocation of responsibilities: 50% leadership and coordination of the Promotional Advertising Review Committee (PARC) and Medical Review Committee (MRC) processes, and 50% Medical Information operations and scientific response support. This individual will collaborate closely with Medical Affairs, Commercial, Legal, Regulatory, Compliance, and other cross-functional stakeholders to ensure high-quality deliverables, efficient review processes, and consistent scientific communication.

Job Requirements

• Demonstrated experience in medical, legal, and regulatory review processes and/or Medical Information within the pharmaceutical or biotechnology industry.
• Terminal degree (PhD, PharmD, or another doctorate)
• An equivalent combination of education and applicable job experience may be considered.
• Urologic oncology and rare disease experience is a plus.
• Excellent oral and written communication skills, including presentation skills.
• Excellent interpersonal skills, with the ability to understand and respond to multiple internal and external stakeholder needs and manage conflict constructively.
• Demonstrated clinical and scientific expertise, including experience working with clinical trials.
• Self-starter who demonstrates accountability and a sense of urgency in delivering impactful results.
• Ability to work collaboratively with Medical Affairs and cross-functional teams.
• Demonstrated leadership and teamwork with peers and internal and external stakeholders, fostering alignment around a shared vision or strategy.
• Ability to travel up to 60%, including overnight travel.

Job Responsibilities

Essential Functions: PARC/MRC Responsibilities

• Leads day-to-day coordination of PARC and MRC submissions and reviews for Medical Affairs materials, ensuring alignment with applicable policies, procedures, and review timelines.
• Serves as the primary Medical Affairs point of contact for PARC/MRC operations and partners with Legal, Regulatory, Compliance, Commercial, and other stakeholders to facilitate timely, high-quality reviews.
• Conducts scientific and medical review of promotional and nonpromotional materials to support accuracy, balance, consistency with approved product information, and appropriate substantiation.
• Manages submission readiness, including intake, reviewer assignment, meeting coordination, status tracking, documentation of decisions, and follow-up on required revisions and approvals.
• Maintains PARC/MRC records, metrics, standard operating procedures, training materials, and process documentation; identifies and implements opportunities to improve review quality and efficiency.
• Provides guidance and training to Medical Affairs and cross-functional partners on PARC/MRC requirements, roles, workflows, and compliant scientific communication practices.

Medical Information Responsibilities

• Supports the development, approval, maintenance, and periodic review of Medical Information resources, including standard response letters, frequently asked questions, clinical dossiers, and other evidence-based materials.
• Triages and responds to unsolicited medical information inquiries from healthcare professionals and other appropriate requestors with timely, accurate, balanced, and appropriately referenced information.
• Supports Medical Science Liaisons with literature searches, evidence evaluation, and development of scientifically rigorous responses to field medical requests; escalates complex or safety-related inquiries as appropriate.
• Supports onboarding, ongoing training, and scientific resource education for the Medical Science Liaison team and contributes to cross-functional training when appropriate.
• Maintains Medical Information inquiry records, response documentation, literature resources, metrics, and relevant procedures in accordance with company requirements and applicable standards.
• Partners with internal stakeholders and external service providers to monitor inquiry trends, identify content or training needs, and drive continuous improvement in Medical Information quality, consistency, and turnaround time.

We offer a competitive salary, employee benefits, and an excellent work environment.

Benefits

• Medical
• Dental
• Vision
• 401k Match
• Paid Time Off
• Employee Assistance Program

We are an Equal Opportunity Employer