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CSL · 2 hours ago

Senior Manager US Advertising & Promotion Lead

King of Prussia, PA

Full-time

Hybrid

Mid, Senior Level

3+ years exp

CSL is a global biotherapeutics leader focused on innovation to improve patient outcomes. The Senior Manager US Advertising & Promotion Lead will ensure compliance with drug promotion regulations, review promotional materials, and provide regulatory guidance to support commercial success.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products

Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance

Adhere to related SOPs and work instructions for established MCC/PRC processes

Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations

Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL’s commercial success

Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes

Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas

Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45

Maintain technical biologics/medical knowledge for assigned therapeutic areas

Actively contribute to the global CSL regulatory community through designated projects and assignments

Review and advise product development teams on communication strategies or tactics regarding investigational products