Director, Medical and Promotional Review

Otsuka Pharmaceutical Companies (U.S.)

. Serve as the primary GMA leader within PRC and MRC processes across the relevant therapeutic portfolio .

Posted 10/22/2026full-timeRemote • United StatesLead💰 $186,489 - $278,875 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in medical review processes, FDA regulations, and therapeutic areas while leading teams to optimize review workflows and ensure compliance. Capable of providing strategic scientific guidance and fostering cross-functional collaboration to enhance content governance and decision-making.

Highest-signal resume keywords

Advanced Scientific Degree10+ Years Pharmaceutical ExperiencePromotional And Medical Review ExpertiseFDA Advertising And Promotion Regulations KnowledgeTeam Leadership And Cross-Functional Influence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Data EvaluationBiostatisticsEvidence EvaluationClaim SubstantiationDocument Lifecycle ManagementMetrics MonitoringOrganizational Change ManagementReview Process OptimizationAI-Enabled Solutions ApplicationReviewer Calibration

Soft Skills

Effective CommunicationInfluencing StakeholdersTeam DevelopmentContinuous Learning PromotionPartnership Building

Tools & Technologies

Veeva VaultAI-Powered MI Solutions

Industry Keywords

PharmaceuticalBiotechnologyHealthcareTherapeutic PortfolioMedical InformationPromotional MaterialsCompliance ConsiderationsOPDP RequirementsCross-Functional CollaborationContent Governance

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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