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.

The Role

General Medical Writing (Sr/Principal Medical Writer) - can be home based in EMEA or US

• Write clinical trial reports and other regulatory documents
• Experience in writing CSRs, Protocols, Investigator Brochures, DSURs, PSURs (safety documents), submission documents
• Provide additional writing and editing services as required (e.g. for publications)
• Advise on the content and format requirements for clinical reports and regulatory documents

Candidates are expected to

• Perform quality control (review) of documents and assess whether specific project related documents comply with regulatory requirements, client requests and ICON SOPs
• Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule
• Responsible for the daily management of assigned medical writing projects
• Liaise with project managers and statisticians to ensure the timely implementation of activities related to the production of reports
• Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems)
• Participate in the training and supervision of new and junior medical writers
• Represent Medical Writing at internal and external meetings
• Assist Business Development with the preparation of proposals and cost estimates for medical writing tasks where applicable

To be successful in the role, you will have:

• Bachelor's degree in a life science/health related sciences, or equivalent

• Medical/Technical writing experience of 3 to 14 years in a clinical research setting
• Outstanding written and verbal interpersonal skills
• Ability to work effectively and cooperatively with other team members
• Understanding of clinical research, the drug development process, and applicable regulatory guidelines

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 through the form below.

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