Director – Advertising and Promotion

🕒 vor 4 Monaten

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $186.489 - $278.875 / Jahr

⏰ Vollzeit

🔴 Experte

👔 Direktor

👻 Geisterscore 42%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Warum dieser Wert:

• Seit 136 Tagen offen.
• Stellen bei diesem Unternehmen werden meist in 36 Tagen besetzt.
• Einmal neu eingestellt.

Jetzt Bewerben

Ähnliche Remote-Jobs finden

Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAlle Stellen

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

• Direct or assist staff members and independently review and approve promotional labeling materials and communications for prescription drug and medical device products • Ensure promotional and training materials meet applicable regulatory and company requirements • Analyze and interpret new regulations and Guidance to Industry documents • Monitor the impact of OPDP correspondence and enforcement actions • Review and approve promotional materials and provide strategic guidance on promotional messaging • Provide strategic regulatory guidance during pre-launch and launch activities • Review promotional claims, scientific communications, disease state education materials, and disease awareness initiatives • Partner cross-functionally with Commercial, Medical, Legal, and Regulatory teams to support launch activities and promotional strategy • Perform final review and approval of promotional materials, sales training materials, and corporate communications • Support review of materials related to complex or highly specialized disease states, including diagnostic or testing considerations, patient identification, and disease education • Submit product promotional materials to OPDP on FDA Form 2253 and archive them according to company policy • Monitor changes in U.S. promotional regulations and corporate policies and procedures and incorporate changes into departmental processes • Participate in cross-functional teams, including the Global Regulatory Team and Global Labeling Team • Participate in launch planning and cross-functional discussions for pipeline and commercialization activities • Provide training to internal employees and affiliates on promotional compliance regulations • Act as a liaison between the company and OPDP and support regulatory discussions related to promotional strategy

🎯 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 • Strong computer skills, including MS Office, Word, Excel, PowerPoint, Veeva PromoMats, CREDO, Outlook, Teams, and Adobe Acrobat • Bachelor’s Degree required • Advanced scientific or clinical degree (e.g., PharmD, PhD, MS) preferred • Experience supporting neurology or other specialty therapeutic areas preferred • Experience interacting with OPDP in support of launch programs preferred • Experience supporting investigational or accelerated approval products preferred • Experience leading, mentoring, or developing promotion compliance team members and influencing cross-functional stakeholders • Ability to work across multifunctional groups • Strong written and oral communication skills

🏖️ Vorteile

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Incentive opportunity

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen