ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Summary: Looking for a Medical Affairs, Medical Reviewer candidate that will be primarily responsible for the medical accuracy review of promotional materials containing medical content for later-stage, post-launch US products.
Responsibilities:
Represent Medical Affairs in medical review of promotional materials for assigned product(s)/therapeutic area(s), as determined by Client’s business needs. May also include medical review of non-promotional materials- Provide timely, medically-relevant, scientifically-sound, and fair-balanced medical/scientific reviews of materials submitted for promotional and/or non-promotional review for assigned product(s)/therapeutic area(s), as determined by Client’s business needs
- Critically review and may provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities.
- Review and approve promotional materials containing information on company’s marketed products as well as the corresponding disease states developed for US markets
- Cross check scientific information in materials against cited references and ensure data included are accurate, within context and presented in a fair/scientifically-balanced manner.
- Verify substantiation of all claims and comparisons. Advise on whether claims are consistent with appropriate approved label
- Participate in meetings, as required, to liaise with client stakeholders and resolve partially accepted or rejected comments after discussing with key stakeholders (med affairs lead, regulatory, legal etc.)
- Advise on materials and events designed and produced by US marketing and medical teams to ensure compliance with company policies and standards for ethical promotion and scientific interactions.
- Based on business needs, candidates may manage other medical information deliverables.
Requirements:
- Advanced bioscience or pharmacy/medical qualification (PharmD, PhD, MD, post-doctoral, etc.).
- Overall, 4-6 years of experience in pharmaceutical industry in reviewing promotional/non-promo materials
- Knowledge of US regulatory guidelines affecting the promotional and non-promotional material review
- Strong accountability, interpersonal and organizational skills, and the ability to work in a cross-functional team environment.
- Excellent verbal and written communication skills and willingness to travel on as needed basis.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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