IQVIA
Overview
IQVIA Pharma Review provides outsourced medical copy review and approval services and advisory services to the pharmaceutical industry. The Final Medical Approver acts as the primary medical and scientific point of contact, providing final approval and expert advice to clients in line with FDA (FDCA), PhRMA, and FTC requirements for pharmaceuticals and medical devices on assets for clients. You will be part of the Medical Quality and Compliance team and work with the IQVIA Pharma Review Account Teams to deliver a seamless content approval and consultative compliance service to US-based clients.
This is a remote role but may require onsite visits to clients.
Responsibilities
Represent Medical Affairs on the content review committee as the lead Medical Reviewer / Approver.
Provide expert final approval services to Pharma Review clients, including approval of relevant assets in line with the client’s strategy and expectations.
Collaborate with Commercial, Regulatory, and Legal partners to provide strategic input and drive alignment as required.
Advise on approval processes and best practices.
Act as an internal escalation point for the 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 and the healthcare landscape, including attending relevant training and sharing outputs.
Serve as the medical approver representative at client meetings as needed.
Engage in recruitment of reviewers and onboarding of new starters as required.
Coach and mentor less experienced team members in technical and leadership skills.
Work with the Compliance Team on internal and client audits as required.
Manage time proactively and track work hours in timesheets in line with operations guidance.
Provide ‘second opinions’ where appropriate.
Escalate issues to the medical director where appropriate.
Be a leader and role model for IQVIA compliance values.
Qualifications
An advanced science or medical degree (PharmD, PhD, MD, PA, NP, RN) strongly preferred.
At least 3-5 years of direct US promotional/medical review experience and ability to work 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 with an approval system like Veeva Promomats and/or Aprimo is desirable.
Job Details
Seniority level: Not Applicable
Employment type: Full-time
Job function: Health Care Provider
Industries: Pharmaceutical Manufacturing
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. Learn more at https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $112,000 - $312,000. The actual base pay offered may vary based on factors including knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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This is a remote role but may require onsite visits to clients.
Responsibilities
Represent Medical Affairs on the content review committee as the lead Medical Reviewer / Approver.
Provide expert final approval services to Pharma Review clients, including approval of relevant assets in line with the client’s strategy and expectations.
Collaborate with Commercial, Regulatory, and Legal partners to provide strategic input and drive alignment as required.
Advise on approval processes and best practices.
Act as an internal escalation point for the 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 and the healthcare landscape, including attending relevant training and sharing outputs.
Serve as the medical approver representative at client meetings as needed.
Engage in recruitment of reviewers and onboarding of new starters as required.
Coach and mentor less experienced team members in technical and leadership skills.
Work with the Compliance Team on internal and client audits as required.
Manage time proactively and track work hours in timesheets in line with operations guidance.
Provide ‘second opinions’ where appropriate.
Escalate issues to the medical director where appropriate.
Be a leader and role model for IQVIA compliance values.
Qualifications
An advanced science or medical degree (PharmD, PhD, MD, PA, NP, RN) strongly preferred.
At least 3-5 years of direct US promotional/medical review experience and ability to work 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 with an approval system like Veeva Promomats and/or Aprimo is desirable.
Job Details
Seniority level: Not Applicable
Employment type: Full-time
Job function: Health Care Provider
Industries: Pharmaceutical Manufacturing
IQVIA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. Learn more at https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $112,000 - $312,000. The actual base pay offered may vary based on factors including knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Depending on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
#J-18808-Ljbffr