Medical Promotional Review Consultant

About the role

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

Responsibilities

• Review of independent scientific/medical/clinical materials for established brand and derivative materials for assigned projects.
• Acting as lead for Medical role during Promotion Review Committee (PRC) meetings and overseeing the medical advertising promotional review process.
• Providing guidance on the Medical/scientific support for PRC and escalating risks to their manager/line manager within the client.
• Participating in cross-functional team meetings and prioritization discussions for the assigned promotion review team.
• Communicating information from promotion review meetings to the broader Medical team when appropriate and escalating risk items to management.
• Prioritizing and executing tactics related to label changes for assigned brands.
• Staying updated with relevant clinical data, publications, and treatment guidelines from medical associations.
• Maintaining awareness of the US regulatory promotional environment by staying informed on FDA regulations and guidance, reviewing untitled and warning letters issued by OPDP, APLB, CDRH, FTC, NAD, or other governing bodies.
• Attending major FDLI, DIA, and other industry/FDA meetings as appropriate.

Requirements

• Strong ability to work independently, with flexibility, and collaborate with clients and team members while working remotely.
• Proven ability to provide strategic direction and innovative, forward-thinking medical guidance, analyzing and interpreting efficacy and safety data.
• Working knowledge of FDA 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 consistent with the FDA approval label.
• Understanding of pharmaceutical advertising/creative review and approval process.
• Proficiency in computer applications and configurations, including Microsoft Office, Adobe Acrobat.
• Proficiency in Veeva Vault Promo Mats or other electronic review platforms.

Skills and Abilities

• Strong ability to work independently, with flexibility, and collaborate with clients and team members while working remotely.
• Proven ability to provide strategic direction and innovative, forward-thinking medical guidance, analyzing and interpreting efficacy and safety data.
• Working knowledge of FDA 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 consistent with the FDA approval label.
• Understanding of pharmaceutical advertising/creative review and approval process.
• Proficiency in computer applications and configurations, including Microsoft Office, Adobe Acrobat.
• Proficiency in Veeva Vault Promo Mats or other electronic review platforms.

Qualifications

• A Bachelor’s degree is required, with a focus in Medical, Science, Marketing, Business, or Communications; a PharmD is highly preferred.
• 5+ years of related experience in the pharmaceutical/biotech industry is required. Related experience from healthcare advertising agencies may be considered.
• Functional experience in pharmaceutical industry medical affairs is required.
• Strong project management experience is required, with experience in the pharmaceutical industry being preferred.

Benefits

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Pay

Compensation is commensurate with experience.

Schedule

Flexible schedule is offered.