Associate Director, Medical Review - PPD

Role Summary

Associate Director, Medical Review - PPD role focusing on medical review for promotional and medical materials, ensuring scientific accuracy, substantiation, quality, and regulatory compliance. Supports Medical Affairs strategies and alliance partnerships, reporting to the Medical Director, Postpartum Depression.

Responsibilities

• Serve as the lead Medical Reviewer for the Promotional Review Committee (PRC) and Medical Review Committee (MRC).
• Provide medical and scientific input on all promotional, medical, and regulatory materials.
• Review and approve promotional and medical content for accuracy and compliance with FDA regulatory standards. Partner with Commercial, Regulatory, Legal, and business units to input strategic alignment.
• Advise on content development and messaging to align with company strategy and therapeutic areas.
• Maintain up-to-date knowledge of advertising regulations from FDA/PhRMA and the healthcare landscape, attending relevant training and sharing outputs.
• Work with Compliance Teams on audits.
• Provide second opinions where appropriate.
• Escalate issues to the medical director when appropriate.
• Manage projects assigned by Medical Affairs, Director/Senior Director.
• Other duties as assigned.

Qualifications

• An advanced science or medical degree (PharmD, PhD, MD, PA, NP, RN) and a minimum of five years of relevant experience is required.
• Previous experience in US promotional/medical review is preferred and able to work independently with minimal oversight.
• Demonstrated ability to critically analyze research design, methods, and outcome measures.
• Pharmacoeconomics experience focusing on quality patient care and patient-oriented outcomes research.
• Commercial/market experience with product launch, clinical development, and Pharmacoeconomics.
• Advanced knowledge of pharmaceutical and medical device guidelines and regulations.
• Experience with an approval system like Veeva PromoMats.

Skills

• Independent work style with ability to work as part of a team.
• Strong analytical and critical thinking skills.
• Effective communication and collaboration with cross-functional teams.
• High ethical standards of integrity and quality.

Education

• Advanced science or medical degree as listed in Qualifications.

Additional Requirements

• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel

• Sedentary work; occasional exertion up to 20 pounds; primarily sitting.
• Close visual acuity for data analysis, transcribing, screen viewing, and extensive reading.
• No substantial exposure to adverse environmental conditions.