Informed Consent Writer in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Informed Consent Writer in United States.

This role sits within a global healthcare intelligence and clinical research organization focused on accelerating the development of new medicines and treatments for patients worldwide. You will play a critical part in transforming complex clinical trial protocols into clear, patient-friendly informed consent documents that support ethical participation decisions. Working across multiple therapeutic areas, you will collaborate with protocol authors, study teams, and clinical operations experts in a fast-paced, deadline-driven environment. The position requires strong scientific understanding combined with the ability to translate technical information into accessible, health-literate language. You will contribute directly to regulatory compliance, patient safety, and trial transparency. This is a highly collaborative role where precision, communication, and project ownership are essential.

In this role, you will be responsible for developing, writing, and managing informed consent documentation that meets regulatory, scientific, and health literacy standards. You will ensure accuracy, clarity, and compliance across all study materials while supporting clinical trial execution.

• Prepare and write informed consent documents using protocol details, templates, and regulatory guidance in clear, lay-friendly language
• Interpret clinical trial protocols to extract relevant study design, objectives, risks, and procedures for participant-facing materials
• Collaborate with protocol authors and clinical teams to ensure full understanding of study requirements and timelines
• Ensure compliance with International Council on Harmonization (ICH) guidelines and applicable regulatory standards for informed consent
• Manage informed consent documentation workflows, including drafting, editing, review cycles, and issue resolution
• Participate in clinical trial team meetings to support timely delivery of consent documentation
• Support continuous improvement initiatives, including process optimization, tool enhancements, and training support for junior staff

This position requires a strong foundation in life sciences combined with experience translating complex scientific or clinical information into accessible content. You should be comfortable working in structured, regulated environments and managing multiple priorities.

• Bachelor’s degree in Life Sciences or related field
• 3–5 years of experience in medical writing, clinical research, or translating scientific content for lay audiences
• Strong understanding of clinical trial protocols and informed consent processes
• Knowledge of ICH guidelines and regulatory requirements related to informed consent
• Proficiency with MS Office tools (Word, Excel, Project) and Adobe Acrobat
• Experience with document management systems and collaborative authoring tools
• Excellent written and verbal communication skills in American English
• Strong organizational, time management, and project coordination abilities
• Ability to work independently while collaborating effectively across global teams
• Detail-oriented mindset with strong adherence to compliance and quality standards

• Competitive salary package aligned with experience and responsibilities
• Health coverage options including medical, dental, and vision (where applicable)
• Retirement and pension savings plans
• Life insurance and disability coverage
• Employee assistance and wellbeing programs
• Learning and development opportunities with structured career growth pathways
• Flexible and collaborative remote working environment (depending on role requirements)