Advertising and Promotional Review Manager
90k - 115k USD
On-site
Full Time
#Marketing
#Pharmaceutical
#FDA
#Adobe Acrobat
#MS Word
#MS Excel
#PowerPoint
#SOP Development
#Project Management
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Advertising and Promotional Review Manager
The Advertising & Promotional Material Review Manager leads the end-to-end review process for promotional and non-promotional content across Axogen's portfolio of brands, with a specific focus on the Avance Nerve Graft® product line. 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 be a key member of the marketing team and will work closely with cross-functional teams, including medical affairs, legal, regulatory, compliance, and sales, to facilitate the timely and compliant development and review of content.
Requirements of the Advertising and Promotional Review Manager
- 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 of the Advertising and Promotional Review Manager
The specific duties of the Advertising and Promotional Review Manager include but are not limited to:
- 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.
Location
111 West Oak Ave., Tampa, FL 33602
#LI-AC1
Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Axogen
0 views
