Sr Principal Medical Writer

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.

Key accountabilities:

• Leads the Medical Writing effort for local requirements in a global, priority program
• Independently leads the MW deliverables for complex global programs
• Acts as the Lead Writer/oversight for clinical sections of eCTDs for Chinese market approval
• Oversees work of internal and/or external writers (consultants, contractors and vendors, depending on operating model)
• Attends governance meetings e.g. for protocols
• No direct people management

Profile requirements

• Minimum requirement of a bachelor’s degree in a scientific or writing discipline; Master’s degree or Ph.D. preferred.
• Minimum of 5-8 years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
• Fluent in English (oral and written).
• Ability to lead discussions on document strategy and alignment across a program
• Strong CTD knowledge and experience in generating clinical CTD documents
• Strong communication skills (verbal, written, and listening) with the ability to interpret and summarize complex data
• Excellent time and priority management; ability to work efficiently under pressure

Why 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.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.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, colour, 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.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.