Director – Advertising and Promotion

🕒 il y a 2 mois

🏖️ New Jersey – Distant

🏖️ New Jersey – Remote

💵 $186 489 - $278 875 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 25%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Otsuka Pharmaceutical Companies (U.S.)

Site WebLinkedInTous les Emplois

1001 - 5000 employés

💊 Pharmaceutique

🏥 Santé

🧬 Biotechnologie

Pharmaceuticals • Healthcare • Biotechnology

Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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