Director, Medical and Promotional Review

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $186.5k - $278.9k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 0%

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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

• Serve as the primary GMA leader within PRC and MRC processes across the relevant therapeutic portfolio • Provide strategic scientific guidance and ensure consistent risk-based decision-making, evidence standards, and content governance • Establish review standards and drive organizational transformation • Conduct and oversee medical review of Medical Information documents, promotional materials, and non-promotional materials • Lead and develop a team of medical reviewers • Provide scientific and business-focused recommendations during cross-functional review discussions • Drive reviewer calibration and alignment across products and therapeutic areas • Lead initiatives to optimize review processes, quality, efficiency, consistency, and scalability • Apply digital and AI-enabled solutions to streamline review workflows • Support content governance, reviewer training, onboarding, and development programs • Oversee document lifecycle management and periodic review of approved materials • Establish and monitor metrics for continuous improvement • Partner with Medical Excellence & Operations and cross-functional stakeholders • Represent GMA on core teams, PRC, and content review and approval processes • Build partnerships with content originators and identify scientific, clinical, and compliance considerations • Collaborate with vendors, agencies, and external partners • Facilitate alignment on scientific messaging, claim substantiation, evidence standards, and clinical data use • Maintain expertise in FDA advertising and promotion regulations, OPDP enforcement trends, FDA guidance, and evolving review practices • Promote best-practice sharing, reviewer development, continuous learning, and process benchmarking

🎯 Requirements

• Advanced scientific degree (PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field) • 10+ years of pharmaceutical, biotechnology, or healthcare industry experience • Significant experience in promotional and medical review and PRC/MRC participation • Strong knowledge of relevant therapeutic diseases, clinical development, FDA advertising and promotion regulations, OPDP requirements, and applicable guidance • Ability to critically evaluate clinical trial data, real-world evidence, and promotional claims • Strong knowledge of biostatistics, evidence evaluation, and claim substantiation • Ability to lead teams, influence cross-functional stakeholders, drive organizational change, and communicate complex scientific information effectively • Experience supporting pre-market approval and commercial launch readiness • Experience leading reviewer teams, reviewer calibration initiatives, and vendor partnerships • Familiarity with MI platforms such as Veeva Vault or emerging AI-powered MI solutions

🏖️ 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 • Other company-provided benefits