Associate Director, Medical Reviewer

Job Overview

IQVIA Pharma Review provides outsourced medical copy review and advisory services to the pharmaceutical industry. As a Final Medical Content Approver, you will act as the primary medical and scientific point of contact providing final approval and expert advice to our clients in line with FDA (FDCA) / PhRMA / FTC requirements.

Job Responsibilities

• Represent Medical Affairs on the content review committee as the lead Medical Content Reviewer/Approver of promotional and non-promotional materials and activities (e.g., congresses).
• Provide expert final approval services to Pharma Review clients which include the approval of relevant assets in line with client's strategy, expectations, and SOPs.
• Effectively collaborate with Commercial, Regulatory, and Legal business partners to provide strategic input and drive alignment as required.
• Advise on approval processes and best practices.
• Act as an internal escalation point for review team on complex jobs.
• Actively participate in and lead internal training for the US market.
• Maintain up-to-date knowledge of advertising regulations from FDA/PhRMA, healthcare landscape, and trends in MLR (e.g., AI).
• Support Business Development in discussions with potential new clients, provide RFP input when required, and support internal Pharma Review (and IQVIA) with expert knowledge of FDA requirements aligned to pharmaceutical materials.
• Account Teams are comprised of a group of reviewers that perform scientific, technical, and quality checks of materials for scientific accuracy, substantiation, quality, and relevant pharmaceutical regulations and codes.
• Represent Medical Affairs on the content review committee as the lead Medical Content Reviewer/Approver of promotional and non-promotional materials and activities (e.g., congresses).
• Provide expert final approval services to Pharma Review clients which include the approval of relevant assets in line with client's strategy, expectations, and SOPs.
• Educate and mentor less experienced members of the team in technical and leadership skills.
• Manage time proactively and track work hours in time-sheet in line with operations guidance.
• Provide 'second opinions' where appropriate.
• Escalates issues to medical director where appropriate.
• Be a leader and role model for core IQVIA compliance values.
• Work with internal IQVIA functions such as business development to contribute to the expansion of the US market.

Qualifications

• An advanced science or medical degree (PharmD, PhD, MD, PhD) strongly preferred or equivalent experience.
• At least 3-5 years of direct US promotional/medical review experience and be comfortable working independently with minimal oversight.
• Demonstrated ability to critically analyze research design, methods, and outcome measures.
• Advanced knowledge of pharmaceutical and medical device guidelines and regulations.
• Experience on an approval system like Veeva Promomats and/or Aprimo.

Pay

The potential base pay range for this role, when annualized, is $120,400.00 - $335,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).