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Overview

The Advertising & Promotional Material Review Manager leads the end-to-end review process for promotional and medical content across Xeris’ portfolio of brands. This role is pivotal in ensuring an efficient and compliant review of all advertising and promotional material, while adhering to regulatory standards, company policies, and legal requirements. The incumbent will collaborate closely with cross-functional teams, including medical affairs, legal, regulatory, compliance, marketing, and sales to facilitate timely and compliant content development and review.

Responsibilities

Material Review & Compliance:

• Oversee the review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with FDA, OPDP, and internal regulatory and submission requirements.
• Act as the subject matter expert for quality control, ensuring all materials meet submission requirements before routing for review.
• Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off.
• Work with marketing operations to ensure all approved materials are correctly archived, distributed, and withdrawn when necessary.
• Serve as the subject matter expert on Veeva PromoMats, guiding best practices for material submission and compliance and provide technical guidance on the system to colleagues as needed.

Cross-Functional Collaboration & Project Management:

• Facilitate and manage Medical, Legal, and Regulatory (MLR) reviews, acting as the liaison between marketing, sales, medical, legal, regulatory, and compliance teams.
• Lead weekly prioritization meetings, balancing reviewer bandwidth and project deadlines to optimize workflow efficiency.
• Schedule, manage, and facilitate live MLR review meetings, summarizing discussions, aligning stakeholders, and ensuring timely reviews.
• Track and oversee annual or as-scheduled re-reviews of materials while ensuring compliance and alignment with business needs.
• Monitor workload forecasts using Veeva dashboards to proactively manage submission volumes and deadlines.
• Communicate material status updates to relevant stakeholders, including business owners, advertising agencies, and fulfillment centers/marketing operations.
• Support and participate in brand and tactical planning meetings to anticipate upcoming review needs.
• Assist Regulatory Affairs team with OPDP (Office of Prescription Drug Promotion) submission upon MLR approval.
• Prepare and distribute meeting agendas for all MLR review meetings, ensuring all stakeholders are aligned on discussion topics.
• Take detailed meeting notes during live review sessions, summarizing key discussions, decisions, and action items.
• Track and follow up on reviewer feedback, outstanding action items, and next steps to ensure timely resolution.

Process Optimization & Training:

• Develop, maintain, and continuously assess and enhance the Ad Promo Review process, training programs, and SOPs to improve efficiency and effectiveness, ensuring alignment with business needs and compliance with regulatory guidelines and requirements.
• Onboard and train new employees and external agencies on the promotional material review process.
• Identify bottlenecks and inefficiencies in the review workflow, continuously evaluating and refining MLR processes to streamline operations, reduce review cycles, and minimize material rejections.
• Track key performance indicators (KPIs) such as review turnaround times and submission quality, implementing improvements as needed.
• Act as a mentor and coach to cross-functional team members, providing guidance on best practices and regulatory requirements.

Communication & Risk Mitigation:

• Act as a neutral facilitator in review discussions, fostering solutions-based problem-solving to address challenges.
• Provide expert consulting on industry regulations, promotional review best practices, and risk mitigation strategies.
• Work closely with cross-functional teams to address and resolve any identified issues.
• Work with marketing operations to ensure promotional material inventory updates are initiated when necessary.
• Perform other duties and responsibilities as requested or assigned to support the overall success of the team and the business.

Qualifications

• Bachelor’s Degree in Business Management, Science, Communication, or a related field.
• 5+ years of experience in Project Management via a content management system, with at least 3 years managing MLR processes (Veeva PromoMats), or Advertising & Promotional Review in the pharmaceutical industry.
• Experience working with Veeva PromoMats or similar review systems.
• Working knowledge of FDA regulations, OPDP guidelines, and pharmaceutical marketing compliance.
• Demonstrated ability to review promotional material, identify false and misleading information, and propose alternative solutions to mitigate risks.
• Proficiency in Adobe Acrobat, MS Word, MS Excel, MS PowerPoint, and ability to learn and adapt to other software tools as needed.
• Competencies: Project Management, Teamwork & Collaboration, Attention to Detail, Self-Starter, Problem Solving, Organizational skills, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
• Working Conditions:
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel up to 30%.
  • Some travel may be required for industry conference attendance.
  • This is a hybrid position based in Xeris’ Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management’s discretion.

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