Director, Advertising and Promotion

🕒 vor 1 Monat

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $186.489 - $278.875 / Jahr

⏰ Vollzeit

🔴 Experte

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Otsuka Pharmaceutical Companies (U.S.)

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1001 - 5000 Mitarbeiter

💊 Pharmazie

🏥 Gesundheitswesen

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Die Otsuka Pharmaceutical Companies (U. S. ) sind ein bedeutender Akteur in der Pharmaindustrie und widmen sich der Entwicklung innovativer Produkte für eine bessere Gesundheit weltweit. Das Unternehmen besteht aus zwei Hauptgesellschaften: Otsuka America Pharmaceutical, Inc. (OAPI), die auf die Vermarktung von Otsuka-entdeckten und lizenzierten Produkten in Nordamerika spezialisiert ist, und Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), die sich auf die klinische Entwicklung und globale Zulassung innovativer Gesundheitslösungen, insbesondere im Bereich der Neurowissenschaften, konzentriert.

Beschreibung

• Directs or assists staff member(s) and independently reviews and approves promotional labeling materials and communications for prescription drug and medical device products. • Ensures that promotional and training materials meet applicable regulatory and company requirements. • Analyzes and interprets new regulations and Guidance to Industry documents, and monitors the impact of Office of Prescription Drug Promotion (OPDP) correspondence and enforcement actions. • Reviews and approves promotional materials and provides strategic guidance on promotional messaging. • Provides strategic regulatory guidance during pre-launch and launch activities, including review of promotional claims, scientific communications, disease state education materials, and disease awareness initiatives. • Reviews promotional materials and communications to ensure consistency with approved product labeling, regulatory requirements, and appropriateness for the intended audience and use. • Partners cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy. • Responsible for final review and approval of promotional materials, sales training materials, and corporate communications. • Supports review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education. • Ensures product promotional materials are submitted to OPDP on FDA Form 2253 in a timely manner and archived as per company policy. • Monitors changes in U.S. promotional regulations and corporate policies and procedures, and incorporates those changes into departmental processes, as appropriate. • Participates in cross-functional meetings and teams, including the Global Regulatory Team (GRT) and Global Labeling Team (GLT). • Participates in launch planning and cross-functional discussions for pipeline and commercialization activities. • Provides training to internal employees and affiliates on promotional compliance regulations, as appropriate. • Acts as a liaison between the company and OPDP and supports regulatory discussions related to promotional strategy, as appropriate.

🎯 Anforderungen

• 6+ years of experience in pharmaceutical advertising and promotion compliance within the biotechnology or pharmaceutical industry • Experience leading or supporting pharmaceutical product launches, including pre-launch planning, launch readiness, and commercialization activities • Experience supporting rare disease products • Demonstrated ability to provide practical, risk-based regulatory guidance in cross-functional commercial environments • Demonstrated ability to balance regulatory risk and business objectives in a fast-paced launch environment • Solid understanding of U.S. regulatory requirements • Excellent understanding of medical concepts and terminology • Strong understanding of FDA advertising and promotion requirements and applicable product labeling • Fundamental understanding of the pharmaceutical industry drug development process

🏖️ Vorteile

• Comprehensive medical, dental, vision, prescription drug coverage • company provided basic life, accidental death & dismemberment • short-term and long-term disability insurance • tuition reimbursement • student loan assistance • a generous 401(k) match • flexible time off • paid holidays • paid leave programs as well as other company provided benefits