Associate Manager, Regulatory Advertising Promotion
Improving quality-of-life through innovations in urology.
Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant is a nimble company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Associate Manager, Regulatory Advertising Promotion is responsible for supporting Urovant’s Regulatory Affairs Advertising and Promotion function and coordinating the Promotional Review Committee (PRC) process, facilitating review and approval of promotional materials for Urovant’s products.
The position is based at Urovant’s site in Irvine, CA and reports to the Executive Director, Regulatory Advertising Promotion
- Facilitate the PRC process, communicating established Urovant standards for creation and dissemination of reviewed materials in accordance with appropriate SOPs.
- Develop and maintain productive working relationships with colleagues and vendors contributing to development, review, and approval of Urovant’s promotional materials, including Marketing/Commercial (and their Agencies), Legal, Compliance, Regulatory Affairs/Labeling, and Medical Affairs.
- Ensure appropriate training of participants in the PRC process by developing and maintaining training materials, as appropriate.
- Schedule and manage PRC meetings, working with Marketing to ensure that agendas are appropriate. Capture and document review comments during PRC meetings.
- Route jobs for review through the designated electronic system(s) for the PRC process.
- Document and ensure follow-up on deviations from the standard PRC process.
- Work closely with the Legal and Compliance departments to address identified issues, as needed.
- Engage with R&D colleagues in Project Management, Clinical, CMC, Regulatory, Quality, and Medical Affairs, as appropriate, to meet team and functional goals.
- Provide promotional labeling and advertising review support to Regulatory Affairs Advertising and Promotion colleagues.
- Proofread final copy to ensure all PRC process feedback has been incorporated.
- Provide final QC review and approval of promotional material.
- Participate in proofreading of product labeling components, package inserts, brief summaries as required, by requested deadlines.
- Support preparation of FDA Form 2253 submissions and requests for advisory comment submissions to FDA’s Office of Prescription Drug Promotion (OPDP), as applicable.
Education and Experience
- Bachelor’s degree in science or health related discipline
- 2 plus years of Regulatory Affairs Ad Prom, Labeling, or equivalent experience.
Essential Skills and Abilities
- Ability to work in a team environment
- Working knowledge of prescription product advertising regulations
- Strong project management skills and ability to perform/prioritize multiple tasks in a fast-paced, deadline-driven environment with limited supervision
- High level interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner
- Exceptional detail-oriented focus, with the ability to promptly assess documents for accuracy as well as consistency
- Accurate and concise oral and written communication abilities
- Able to innovate, analyze, and solve problems
- Exceptional communication skills, both verbally and in writing
- Proficiency with software/systems (e.g. Veeva, Microsoft Word/Excel/PowerPoint)
- A commitment to collaborative teamwork and the maintenance of a professional culture based on trust and mutual respect