Some relevant industry experience is preferred, however, this position does not require heavy regulatory expertise.
Editing/ review background and the ability to follow up with internal stakeholders.
Review Committee Process Leads (RCPLs) participate in the formal review process of advertising and promotional materials; manages the day-to-day review process; and validates final production of all advertising and promotional materials;
Trains and collaborates with internal and external business partners to ensure compliance with appropriate Medical, Legal, Regulatory, corporate, and US Food and Drug Administration (FDA), rules, regulations and guidance documents; manages business partners and assists with the timely execution of project timelines;
Identifies project discrepancies from appropriate rules, regulations and guidance documents that may potentially have a negative impact on the organization and provides recommendations for resolution; and
Actively participates in meetings of the Review Committee with particular attention to the review, assessment, and validation of advertising and promotional materials with respect to established MLR, corporate, and FDA rules, regulations, and guidance documents; ensures copyright compliance for reference materials used on advertising and promotional materials
Identifies project discrepancies that potentially may have negative medical, legal, regulatory, corporate, or budgetary impact and provide recommendations for resolution.
Preferred – 5+ years product and customer segment knowledge as it relates to vaccines/pharmaceuticals
Preferred – 5+ years of advertising and promotional material review process experience
Understanding of CBER, FDA, and AMA/APA style guidelines as they relate to vaccines/pharmaceuticals
Source: Job Diva – Job Listing