Associate Director, Medical Affairs

UroGen Pharma, Inc•,

4h•Hybrid

About The Position

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.

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)
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.

Nice To Haves

An equivalent combination of education and applicable job experience may be considered.
Urologic oncology and rare disease experience is a plus.

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.
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.