Director – Advertising and Promotion

🕒 June 29

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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