Informed Consent Writer

Informed Consent Writer

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

About

The Informed Consent Writer (ICW) is responsible for preparing informed consent documents that disclose information about a clinical trial using health literate language to help a candidate make an informed decision about trial participation. The ICW will work across multiple therapeutic areas using client tools, systems, guidelines, templates, and processes.

Key Skills and Competencies

Scientific Knowledge/Health Literacy:

• Understanding of protocol structure and knowledge of relevant information for informed consent documents.
• Understanding of clinical trial operations with specific knowledge of informed consent forms.
• Ability to prepare, with minimal supervision, a summary of clinical trial design, objectives, and activities for a lay audience using established guidelines and governmental regulations in a clear, concise, and health-literate format.
• Understanding of appropriate International Council on Harmonization (ICH) and regulatory guidance pertaining to Informed Consent.

Technology Skills:

• Technical expertise in MS Office (Word, Excel, Project) and Adobe Acrobat.
• Experience working in document management systems; managing workflows.
• Experience with collaborative authoring and review tools.
• Understanding of structured content management concepts.
• Flexibility in adapting to new tools and technology.

Other Skills:

• Ability to work in a deadline-driven environment, both independently and collaboratively.
• Complete fluency in reading and writing American English.
• Excellent communication skills (email responses, meeting presentations).
• Effective time management, organizational, and interpersonal skills.
• Customer focus.
• Strong project management skills.

Education and Experience

• Life sciences degree.
• 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience.

Responsibilities

• Read and understand protocol-specific design, objectives, and study procedures.
• Prepare study-specific informed consent documents using established templates, information from protocols, content libraries, and glossaries (when appropriate), and required risk language.
• Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline.
• Write, edit, and review informed consent documents that reflect the principles of health literacy.
• Manage informed consent writing projects, including the design, planning, and preparation of documentation in support of clinical development.
• Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s).
• Resolve document issues relating to informed consent.
• Support Global Clinical Trial Operations with informed consent process expertise and study-specific support.
• Possible participation in the orientation and coaching of junior team members.
• Possible participation in initiatives to improve medical writing processes and standards.
• Support tool development, enhancements, and testing, as applicable.
• Ensure compliance with company training and time reporting.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Benefit examples include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, a Global Employee Assistance Programme (LifeWorks), life assurance, and flexible country-specific optional benefits.

Inclusion and Belonging

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here. 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.

Key skills/competency

• Informed Consent Writer
• Health Literacy
• Clinical Trial Operations
• Protocol Development
• ICH Guidelines
• MS Office
• Document Management Systems
• Medical Writing
• Project Management
• Scientific Communication