About the role

The Sr Manager, Promotional Review Operations is responsible for leading the end-to-end Promotional Review Committee (PRC) review process to ensure promotional and non-promotional materials are compliant, accurate, balanced, and aligned with internal standards and applicable regulations. This role partners closely with Medical, Legal, Regulatory, Marketing, and Commercial stakeholders to drive efficient, high-quality reviews while enabling on-time delivery of business priorities.

The Sr Manager, Promotional Review Operations provides operational leadership for the review workflow by coordinating intake, routing, meetings, documentation, comment resolution, version control, and final disposition. The role supports business function owners as they prepare, review, and approve materials, while continuously improving cycle times, process clarity, and stakeholder experience.

The ideal candidate has experience operating PRC review processes in a pharmaceutical or biotechnology environment; is comfortable influencing cross-functional leaders; and brings structure, clarity, and measurable process improvements to fast-paced content development and launch timelines.

Essential Functions

PRC Operations & Review Process Leadership

• Own and manage the end-to-end PRC review workflow for promotional and non-promotional materials, ensuring timely, compliant, and well-documented outcomes.
• Maintain the master PRC review schedule to provide visibility into active submissions, upcoming reviews, approval needs, bottlenecks, and launch-critical priorities across business functions.
• Ensure consistent application of PRC policies and review standards across materials and teams while enabling appropriate flexibility for risk-based review.

Cross-Functional Partnership & Facilitation

• Partner with senior stakeholders across Medical Affairs, Legal, Regulatory, Compliance, Marketing, Commercial, and Agency partners to align expectations, timelines, and review readiness.
• Plan, facilitate, and document PRC review meetings (live or asynchronous), ensuring clear decisions, ownership, and follow-up actions.
• Proactively identify bottlenecks and risks (e.g., incomplete submissions, major claim changes, labeling updates), surface trade-offs, and drive resolution with a customer-service mindset.

Governance, Compliance & Audit Readiness

• Work with leadership to maintain PRC governance, including RACI, escalation pathways, submission standards, meeting cadence, and documentation requirements.
• Manage tracking of FDA submissions, OPDP correspondence, advisory comments, approval records, version histories, and related compliance documentation in partnership with Regulatory, Legal, Medical, and Compliance stakeholders.
• Monitor adherence to policies and SLAs; prepare metrics and documentation to support internal audits, compliance reviews, and regulatory inspections as needed.

Tools, Metrics & Continuous Improvement

• Own and evolve PRC SOPs, playbooks, templates, and training (e.g., submission checklists, claims substantiation expectations, reference standards, annotation conventions).
• Drive adoption and effective use of PRC technology (e.g., Veeva PromoMats, Vodori, or equivalent) including workflows, user support, taxonomy/metadata, and reporting.
• Track and report cycle time, throughput, right-first-time submissions, and rework drivers; lead continuous improvement initiatives to reduce friction while maintaining compliance and quality.

Content Lifecycle, Claims & Labeling Alignment

• Coordinate with Medical/Regulatory/Legal to ensure promotional claims remain consistent with the current label, clinical data, and guidance, and that required references/substantiation are available and traceable.
• Support content lifecycle management (creation, review, approval, expiration/withdrawal, and periodic re-review) and ensure impacted materials are assessed following labeling updates or safety changes.
• Enable launch and field readiness by partnering with Commercial/Training teams to align review timelines with deployment, distribution, and communication plans.

Qualifications

• Bachelor's degree in Life Sciences, Business, Marketing, Communications, Healthcare Administration, or a related field.
• 5-8+ years of experience in pharmaceutical or biotechnology industries, with meaningful experience supporting or managing PRC operations, promotional review workflows, compliance documentation, and cross-functional review coordination.
• Demonstrated experience leading or managing PRC operations, including workflow design, meeting facilitation, and stakeholder management.
• Strong understanding of promotional regulations and guidance and common expectations for claims substantiation, fair balance, and use of references (in partnership with functional experts).
• Hands-on experience with PRC systems (e.g., Vodori, Veeva PromoMats, Aprimo, or equivalent) and comfort producing metrics, dashboards, and operational reporting.
• Proven ability to influence cross-functional leaders and drive alignment in high-volume, deadline-driven environments.
• Experience supporting promotional review platforms and content repositories such as Veeva PromoMats, Vodori, Zotero, SharePoint, Teams, or similar systems, including workflow support, user access coordination, version control, reference management, and audit-ready documentation.
• Experience building, scaling, and improving governance models, SOPs, and compliance-ready documentation across brands, portfolios, or regions.
• Excellent communication and facilitation skills; highly organized with strong attention to detail, judgment, and ability to manage multiple reviews in parallel.

Work Authorization: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

• FULLY REMOTE WORK ENVIRONMENT
• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS -In 2026 we will observe 14 holidays
• RETIREMENT - 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) - PPO & HDHP - Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION - Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE - Company Paid 2 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More