Medical Promotional Review Consultant - Part-Time

Responsibilities

• Provide 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.
• Review independent scientific/medical/clinical materials for Established brand and Derivative materials for assigned projects.
• Act as lead for Medical role during Promotion Review Committee (PRC) meetings and oversee the medical advertising promotional review process.
• Provide guidance on the Medical/scientific support for PRC and if necessary, elevate risks to their manager/line manager within the client.
• Participate in cross-functional team meetings and prioritization discussions for the assigned promotion review team.
• Communicate information provided during promotion 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.
• Maintain awareness of the US regulatory promotional environment by staying updated on FDA regulations and guidance, reviewing untitled and warning letters issued to pharmaceutical companies published by OPDP, APLB, CDRH, FTC, NAD, or other governing bodies.
• Attend major FDLI, DIA, and other industry/FDA meetings as appropriate.

Requirements

• 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 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 made consistent with the FDA approval label.
• Understanding of pharmaceutical advertising/creative review and approval process.
• Proficiency in computer applications and configuration, 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 are 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 preference in the pharmaceutical industry.