Advertising and Promotional Review Manager – Biologics/Pharma

Advertising and Promotional Review Manager – Biologics/Pharma

Requirements

• Bachelor’s Degree in Business Management, Science, Communication, or a related field.
• 5+ years managing MLR processes (Veeva PromoMats), Advertising & Promotional Review in the pharmaceutical or biologics industry.
• Extensive experience working within Veeva PromoMats and supporting submissions to CBER or OPDP
• Working knowledge of FDA regulations, OPDP or CBER guidelines, and pharmaceutical biologics/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.
• Experience developing and implementing SOPs, work instructions, guidelines and policies
• Impressive organization, content and project management skills
• Familiarity with AMA guidelines for referencing
• Experience and proficiency in managing multiple projects with various internal and external stakeholders
• Ability to think strategically, work collaboratively, and communicate effectively across all functions
• Flexibility and the ability to develop creative approaches to accomplish work and problem-solve
• Strong attention to detail and the ability to multi-task in a fast-paced environment
• Strong interpersonal and influencing skills

Responsibilities

• Oversee the review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with FDA, CBER/OPDP, and internal regulatory and submission requirements.
• Assist Regulatory Affairs team with submission to CBER (Center for Biologics Evaluation and Research) upon MLR approval.
• Serve as a 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.
• Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off.
• PRC meeting management and facilitation: Schedule, manage, and facilitate live MLR review meetings, summarizing discussions, aligning stakeholders, and ensuring timely reviews. This includes but is not limited to agenda planning, calendar management, handling of expedited reviews, and capturing consensus outcomes during live discussion meetings.
• Track and follow up on reviewer feedback, outstanding action items, and next steps to ensure timely resolution.
• Communicate material status updates to relevant stakeholders.
• Support and participate in brand and tactical planning meetings to anticipate upcoming review needs.
• Develop, maintain and continuously assess and enhance the Ad Promo Review process, 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 with key stakeholders 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.
• Act as a neutral facilitator in review discussions, fostering solutions-based problem-solving to address challenges.
• Work closely with cross-functional teams to address and resolve any identified issues.
• Perform other duties and responsibilities as requested or assigned to support the overall success of the team and the business.

Preferred Qualifications

No preferred qualifications provided.