Associate Director, Medical Reviewer

Associate Director, Medical Review (MLR)

Location: Home-based in USA

IQVIA Pharma Review provides outsourced medical copy review and approval services 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 the requirements of the FDA (FDCA) / PhRMA / FTC for pharmaceuticals and medical devices on assets for clients. You will be expected to be part of the relevant content review teams eg Project/ Product Review Teams (PRT).

In this role and as part of the Medical Quality and Compliance team you will be working alongside and as part of the IQVIA Pharma Review Account Teams to deliver a seamless and consistent approach to content approval and consultative compliance advice to the US based clients and business and provide some account management services.

In addition, you will be expected to support Business Development in discussions with potential new clients, provide RFP input when required, support internal Pharma Review (and IQVIA) with expert knowledge of FDA requirements aligned to pharmaceutical materials

The 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.

This is a remote role but may require onsite visits to clients.

Job Responsibilities:

• Represent Medical Affairs on the content review committee as the lead Medical Cotnet Reviewer / Approver of promotional and non-promotional materials and activities (eg 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 eg AI) including attending relevant training, and share relevant outputs
• Medical approver representative at client meetings as needed
• Active involvement in recruitment of reviewers and onboarding new starters as required.
• Coaching and mentoring of less experienced members of the team in technical and leadership skills
• Work with Compliance Team on internal and client audits as required
• 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
• Currently no line management but may be required in future

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 desorable