Medical Writer I - Imaging

Job title: Medical Writer I - Imaging

About the Role

Join ICON’s Medical Imaging team as a Medical Writer I. You will produce high-quality imaging-related documents to support clinical studies and regulatory submissions, including BICR documentation and imaging protocol understanding. You will work with cross-functional teams and sponsors to gather information and ensure timely, high-quality delivery.

What You'll Do

• 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 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 We're Looking For

• Advanced degree in a scientific discipline (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 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.

Compensation & Benefits

Our benefits package is competitive and tailored to support you and your family. Highlights include:

• Various annual leave entitlements.
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits (childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others).