Medical Affairs Lead – PARC/MRC & Info Ops

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

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%.