Senior Manager, Promotional Review Process Lead, USRA- Advertising & Promotion

About the Role

Key Responsibilities

• Lead and manage the end-to-end review and approval lifecycle of promotional materials, utilizing electronic review system, Veeva PromoMats
• Collaborate cross-functionally with Commercial, Regulatory, Legal, Medical, and Agency partners
• Lead the coordination of the USRC activities and ensure that the promotional review process is conducted both in a highly compliant and efficient manner
• Facilitate high quality USRC meetings, including agenda planning, time management and accurately capturing consensus comments at live reviews
• Review and ensure that all submissions are complete and meet certain quality standards prior to circulation to reviewers and provide proactive guidance as needed
• Collaborate with Commercial and Agency partners on submission timelines to meet business deadlines and initiatives
• Track promotional materials from inception through approval and provide actionable feedback where there are workflow issues
• Monitor document lifecycle, including reapprovals and expiry of materials in accordance with USRC SOP
• Involved in planning and execution of product launches, new indications, and label updates in partnership with Commercial and Regulatory
• Provide continuous training to internal and external stakeholders on USRC process and systems, including new hire and refresher training
• Proactively lead project work supporting continuous improvement and process innovation, and partnering with the USRC team to share ideas and support team growth
• Track USRC reviewer comments and elicit necessary revisions from stakeholders
• Facilitate and manage escalation meetings for USRC materials as needed
• Create FDA Form 2253 and coordinate with Regulatory team to complete eCTD compliant submissions to OPDP
• Support in managing, maintaining, and improving Veeva PromoMats functionality and training documentation
• Collaborate with management to identify USRC process efficiencies and enhancements
• Manage promotional review process associates, including contractors or consultants

Requirements

• Bachelor's degree preferred
• 5+ years of experience in equivalent or similar industry with at least 2-3 years of experience working with promotional review committees
• Experience with Veeva PromoMats or similar electronic management system
• Basic knowledge of pharmaceutical promotional regulations and submission requirements
• Experience managing complex projects, ensuring timelines, deliverables, and stakeholder communications are effectively handled
• Prior experience coordinating with high performing committees or similar groups
• Ability to foster a team environment while collaborating cross-functionally
• Strong organizational skills to manage multiple projects, timelines, and committee activities simultaneously
• Excellent written and verbal communication skills
• Ability to evaluate information, consider alternatives, and make informed recommendations
• Ability to resolve problems logically, quickly and proactively
• Exceptional attention to detail
• Proficient in Microsoft Office, Adobe, and Veeva PromoMats
• Must live a commutable distance to Florham Park, NJ, with office presence required at least 50% of the time per month

Nice to Have

• Experience with electronic submission systems and regulatory documentation
• Previous leadership or management experience in a regulatory or promotional review setting

Qualifications

• Educational background with a preference for a Bachelor's degree

Benefits & Perks

• Base salary range of $135,000 - $165,000
• Additional benefits, bonus, long-term incentive, and allowances are available but not specified