ICON & You – The Potential of Together
Experienced Senior Medical Writer needed for niche Regulatory Medical Writing role.
ICON plc is looking for a Senior Medical Writer who is experienced in regulatory strategic writing to work with our embedded, FSP model alongside some of the world’s top leading pharmaceutical companies.
As a Senior Regulatory Strategic Medical Writer, you are responsible for providing support to one or more Therapeutic Areas (TA) as designated by the Regulatory Strategic Writing (RSW) leadership. The Medical Writer provides support for the preparation and submission of critical regulatory documents, including briefing books and responses to health authority information requests, using available reference materials. In addition, you are responsible for ensuring the accuracy and quality of submission-ready documents using established Regulatory Strategic Writing (RSW) processes. As the Medical Writer, you partner with the regulatory strategic TA lead, other RSW contributing staff, as well as the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership.
Responsibilities include but are not limited to:
Preparing, authoring/writing, contributing, editing, and reviewing high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities.
Documents include:
Requirements:
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
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