Medical Writer - Imaging Writing

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center 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:
This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON’s Clinical Research Services group. Our remit is to produce high quality documents supporting clinical studies and regulatory submissions.

The primary responsibilities and accountabilities of our Medical Writer – ICON Medical Imaging are:

• Prepare documentation for Blinded Independent Central Review (BICR) implementation for clinical trials

• Understand the imaging aspects of sponsor clinical protocols

• Understand image acquisition modalities

• Understand image assessment criteria

• Independently write and finalize Medical Imaging documents, including:

  • Site Imaging Manual (SIM)

  • Independent Review Charter (IRC)

  • Independent Review Training Manual (IRTM)

• Liaise with internal groups, i.e., Medical and Scientific Affairs, Imaging Operations, and Clinical Operations to obtain necessary and relevant information and to deal with queries

• Independently interact with sponsors to obtain necessary information and deal with queries through effective decision making

• Inform the Manager-Medical Writing/designee of document status relative to quality and timelines

• Independently provide additional writing and editing services as required

What you need:

• Advanced degree in a scientific discipline, preferably PhD, PharmD or MD

• 2+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting

• Knowledge of imaging guidelines for clinical trials, such as the FDA “Clinical Trial Imaging Endpoint Process Standards Guidance for Industry”

• Strong written and verbal interpersonal skills

• Good computer literacy

• Ability to work effectively and cooperatively with cross-functional teams

• A desire to be a key part of a global network of services that lead to better outcomes for its clients, its people and for patients…apply now and Own IT@ICON!

Why join us?

Ongoing development is vital to us, and as a Medical Writer, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

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.

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