Senior Consultant for Regulatory Promotional Review

2 weeks ago

Western Springs, Illinois, United States ProPharma Group Full time

For over two decades, ProPharma has enhanced patient health and wellness by delivering expert guidance that empowers biotech, medical device, and pharmaceutical organizations of all sizes to confidently navigate scientific advancements and launch new therapies. As the largest Research Consulting Organization (RCO) globally, ProPharma collaborates with clients through a comprehensive advise-build-operate model throughout the entire product lifecycle. With extensive expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, and R&D technology, ProPharma provides a complete suite of customizable consulting solutions designed to mitigate risks and expedite our partners' most significant drug and device initiatives.

Position Overview

The Senior Consultant for Regulatory Promotional Review is tasked with:

  • Delivering compliant and precise solutions from a regulatory affairs perspective concerning promotional and advertising reviews, while equipping marketing with competitive strategies for consumer, healthcare provider, and managed care materials across all assigned brands.
  • Leading the Regulatory role during Promotion Review Committee (PRC) meetings and overseeing the promotional review process, along with other promotion-related activities for designated brands or therapeutic categories.
  • Assessing materials for product launches, growth brands, established brands, and derivative projects.
  • Providing insights on potential risks to the PRC and, if necessary, escalating concerns to their manager within the client organization.
Key Responsibilities
  • Reviewing and approving all promotional and non-promotional materials for assigned PRC, demonstrating a robust understanding of regulatory advertising and promotion regulations, as well as FDA guidelines.
  • Participating in prioritization discussions for the assigned PRC.
  • Evaluating opportunities consistent with FDA-approved labeling.
  • Offering regulatory guidance regarding advertising and promotional materials, new campaigns, and launch strategies.
  • Counseling job owners on planning for the review process, including timing considerations and relevant guidance documents.
  • Communicating insights from promotion review meetings to the broader regulatory team when appropriate.
  • Clarifying rationale and representing regulatory feedback on review materials during live PRC meetings.
  • Collaborating with Agency Partners and Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use.
  • Partnering with job owners and stakeholders in executing job reapprovals and tactics related to label modifications for assigned brands.
  • Monitoring the US regulatory promotional landscape by staying informed on FDA regulations and guidelines.
  • Reviewing untitled and warning letters issued to pharmaceutical companies by OPDP, APLB, CDRH, FTC, NAD, or other governing bodies.
  • Attending major industry meetings such as FDLI, DIA, and other relevant FDA gatherings as appropriate.
Essential Skills and Qualifications
  • Ability to work independently with flexibility while effectively connecting and collaborating with clients and team members in a remote environment.
  • Proven capability to provide strategic direction and innovative regulatory guidance, along with analyzing and interpreting efficacy and safety data.
  • Working knowledge of FDA and pharmaceutical regulatory and compliance guidelines regarding advertising and promotion, including product launches.
  • Deep understanding of the advertising and creative development process.
  • Familiarity with the pharmaceutical review and approval process.
  • Experience leading activities necessary for promotional OPDP submissions.
  • Experience utilizing new and social media platforms for the promotion of prescription drugs in the US.
  • Proficiency in computer applications, including Microsoft Office and Adobe Acrobat, as well as familiarity with Veeva Vault Promo Mats or other electronic review platforms.
Educational Background

A Bachelor's degree is required, preferably in Medical, Science, Marketing, Business, or Communications; a PharmD is highly regarded.

Experience Requirements
  • A minimum of 7 years of relevant experience in the pharmaceutical or biotech industry is required, with consideration for related experience from healthcare advertising agencies.
  • Functional experience in regulatory advertising and promotion is essential.
  • Previous experience in medical advertising and promotional review, marketing operations, sales, or communications is preferred.
  • Experience in product launch or advertising agency account management is advantageous.
  • Strong project and process management experience is required, preferably within the pharmaceutical industry.
We celebrate our differences and strive to create a workplace where each individual can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. As an Equal Opportunity Employer, we provide a safe environment where all employees feel empowered to succeed.

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