Sr. Promotional Review Associate - Contractor

Responsibilities

• Support the end-to-end review and approval lifecycle of promotional materials, utilizing electronic review system, Veeva PromoMats
• Cross-functionally collaborate with Commercial, Regulatory, Legal, Medical, and Agency partners
• Coordinate USRC activities and support the review process to help ensure efficiency and compliance
• 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
• Maintain document lifecycle, including reapprovals and expiry of materials in accordance with USRC SOP
• Perform comment verification on documents to ensure USRC advice has been incorporated correctly; follow-up with individual USRC Reviewers when further clarification is needed
• Proofread materials for accuracy, grammar, misspellings, punctuation, formatting, and stylistic errors
• Check materials for alignment to Brand style guide, USRC guidelines, and corporate policies
• Provide training on USRC process and Veeva Promomats as needed
• Coordinate logistics for USRC escalation meetings, as per USRC SOP, as needed
• Aid in preparation of OPDP submission materials, including supporting documentation, and coordinate with the Regulatory team on final FDA Form 2253 filings

Qualifications

• Bachelor’s degree preferred
• 3+ years of experience in equivalent or similar industry with at least 2 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 supporting and coordinating complex projects, ensuring timelines, deliverables, and stakeholder communications are effectively handled
• Prior experience coordinating with high performing committees or similar groups
• Ability to foster collaboration and teamwork while working cross functionally with stakeholders at varying levels
• Strong organizational skills to support the management of priorities, timelines, and committee activities simultaneously
• Excellent written and verbal communication skills to effectively convey feedback, decisions, and rationale to stakeholders
• Ability to evaluate information, consider alternatives, and provide input or recommendations to stakeholders
• Exceptional attention to detail, with the ability to identify and correct errors in promotional materials, ensure accurate incorporation of reviewer comments, and maintain precise version control in Veeva PromoMats
• Proficient in Microsoft Office, Adobe, and Veeva PromoMats