Medical Promotional Review Consultant

Job Description:

The Medical Promotional Review Consultant is responsible for providing compliant, medically accurate and scientifically sound solutions while providing marketing with competitive solutions for consumer, healthcare provider and managed care promotional and non-promotional materials.

This includes reviewing independent scientific/medical clinical materials for product launch, growth brand and established brand and derivative materials for assigned projects. Additionally, the consultant will act as lead for medical role during promotional review committee (PRC) meetings and oversee the medical advertising promotional review process.

• Key Responsibilities:
• Provide detailed review of promotional, disease awareness and medical only materials for scientific and medical accuracy.
• Participate in cross functional team meetings and prioritization of discussions for the assigned promotional review team.
• Communicate information provided during promotional review meetings to the broader Medical team when appropriate and elevate risk items to management.
• Partner with job owners and other stakeholders in the execution and creation of tactics related to label changes for assigned brands.
• Stay up to date with relevant clinical data, publications, and treatment guidelines published by medical associations.
• Monitor Brazilian regulatory promotional environment by staying up-to-date on Anvisa regulations and guidance's, reviewing untitled and warning letters issued to pharmaceutical companies published by OPDP, APLB, Center for Devices and Radiological Health (CDRH), Federal Trade Commission (FTC), National Advertising Divisions (NAD) or other governing bodies.

Necessary Skills and Abilities:

• Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
• Proven ability to provide strategic direction and innovative, forward thinking medical guidance and analyze and interpret efficacy and safety data.
• Working knowledge of Anvisa and Pharmaceutical regulatory and compliance guidelines on advertising and promotion.
• Deep understanding of scientific data from clinical trials, review articles, medical textbooks, etc. and how this data supports claims made consistent with the Anvisa approved label.
• Understanding of pharmaceutical advertising/creative review and approval process.
• Proficiency in computer applications and configuration, including MS Office, Adobe Acrobat.
• Proficiency in Veeva Vault, Promo Mats or other electronic review platforms.

Requirements:

• A Bachelor's degree is required, focus in Medical, Science, Marketing, Business or Communications; a PharmD is preferred.
• 5 years of related experience in the pharmaceutical/biotech industry is required. May consider related experience from healthcare advertising agency.
• Functional experience in pharmaceutical industry medical affairs is required.
• Strong project management experience in pharmaceutical industry is preferred.