Director, Medical and Promotional Review

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary leader of GMA within PRC and MRC processes across the relevant therapeutic portfolio.

• Offer strategic scientific direction and ensure consistent risk-informed decision-making, evidence standards, and content governance.

• Set review standards and drive organizational transformation.

• Conduct and supervise medical reviews of Medical Information documents, promotional materials, and non-promotional materials.

• Lead and mentor a team of medical reviewers.

• Provide scientifically and business-oriented recommendations during cross-functional review discussions.

• Facilitate reviewer calibration and alignment across products and therapeutic areas.

• Spearhead initiatives to enhance review processes, quality, efficiency, consistency, and scalability.

• Utilize digital and AI-enabled solutions to optimize review workflows.

• Assist with content governance, reviewer training, onboarding, and developmental programs.

• Oversee document lifecycle management and the periodic review of approved materials.

• Establish and track metrics for continuous improvement.

• Collaborate with Medical Excellence & Operations and cross-functional stakeholders.

• Represent GMA on core teams, PRC, and in content review and approval processes.

• Build relationships with content creators and identify scientific, clinical, and compliance considerations.

• Work alongside vendors, agencies, and external partners.

• Promote alignment on scientific messaging, claim substantiation, evidence standards, and clinical data usage.

• Maintain expertise in FDA advertising and promotion regulations, OPDP enforcement trends, FDA guidance, and evolving review practices.

• Encourage the sharing of best practices, reviewer development, continuous learning, and process benchmarking.

⛳️ Requirements

• Advanced scientific degree (PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field).

• Over 10 years of experience in the pharmaceutical, biotechnology, or healthcare industry.

• Extensive experience in promotional and medical review as well as PRC/MRC participation.

• Strong understanding of relevant therapeutic diseases, clinical development, FDA advertising and promotion regulations, OPDP requirements, and applicable guidance.

• Ability to critically assess clinical trial data, real-world evidence, and promotional claims.

• Robust knowledge of biostatistics, evidence evaluation, and claim substantiation.

• Proven capability to lead teams, influence cross-functional stakeholders, drive organizational change, and effectively communicate complex scientific information.

• Experience in supporting pre-market approval and readiness for commercial launch.

• Background in leading reviewer teams, reviewer calibration initiatives, and vendor collaborations.

• 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.