Icon plc medical writer 1 job: Imaging

Company Name: Icon plc

Location: Chennai

Job Title: Medical Writer I – Imaging

Reference Code: JR112117

Employment Type: Full-time, Office-Based

Industry: Clinical Research Services

Icon plc stands as a global leader in clinical research, committed to advancing and improving patients’ lives. Our ‘Own It’ culture, rooted in values like Accountability & Delivery, Collaboration, Partnership, and Integrity, sets us apart in the pharmaceutical sector. We aspire to be the preferred Clinical Research Organization, delivering excellence at every stage of drug development.

Company Vacancies List

Position Title: Medical Writer I – Imaging

Location: Chennai

Reference Code: JR112117

Employment Type: Full-time, Office-Based

Job Description

About the Department & Responsibilities

Join our esteemed Medical Writing team, an integral part of ICON’s Clinical Research Services group, dedicated to producing high-quality documents supporting clinical studies and regulatory submissions.

Key Department Values:

1. Passionate about partnership
2. Quality without compromise
3. Flexibility in a dynamic environment

Primary Responsibilities:

• Prepare documentation for Blinded Independent Central Review (BICR) implementation for clinical trials
• Understand the imaging aspects of sponsor clinical protocols
• Independently write and finalize Medical Imaging documents, including Site Imaging Manual (SIM), Independent Review Charter (IRC), Independent Review Training Manual (IRTM), etc.
• Liaise with internal groups, such as Medical and Scientific Affairs, Imaging Operations, and Clinical Operations
• Independently interact with sponsors to obtain necessary information and address queries
• Inform the Manager-Medical Writing/designee of document status relative to quality and timelines
• Provide additional writing and editing services as required

Requirements:

• 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 healthcare 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

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