Sr. Informed Consent Medical Writer

Job Description

The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance with public disclosure of clinical trials and their results. The Senior Informed Consent Medical Writer is responsible for developing informed consent deliverables per company process and standards, ensuring compliance with internal policy, regulatory requirements, and health literacy principles.

With minimal oversight, the Senior Informed Consent Medical Writer:

• Demonstrates independence in managing multiple study-specific informed consent deliverables per company and regulatory requirements, leveraging study protocols, established templates, libraries, glossaries, and risk language.
• Applies an in-depth knowledge of informed consent medical writing responsibilities, including design, planning, writing, editing, and review of accurate, clear, high-quality documents that reflect the principles of health literacy
• Collaborates with protocol authors and clinical teams to ensure comprehensive understanding of required timelines, protocol details, and study-specific procedures that impact informed consent documents.
• Applies understanding of clinical development, study protocols (eg, design, objectives, and study procedures), relevant regulations, disease areas, and company products.
• Applies critical thinking, problem solving, and negotiation skills to identify innovative solutions to challenges across the informed consent medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics.
• Applies knowledge of informed consent-specific tools and technology platforms.
• Participates in or leads initiatives to improve informed consent processes and standards
• May participate in orientation and coaching of junior team members or contract writers.

Qualifications

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine)

Experience and Skills

• 5+ years of relevant medical writing experience
• Demonstrated experience presenting complex medical concepts in a clear, concise, and health-literate format; strong knowledge of health literacy principles preferred.
• Ability to prepare, with minimal oversight, a summary of a clinical trial design, objectives and activities for a lay audience per established guidelines and government regulations.
• Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively with cross-functional teams.
• Demonstrated critical thinking and problem-solving capabilities.
• Ability to meticulously review own work to ensure document quality (eg, accuracy, completeness, reading level, grammar, and alignment with document requirements)
• Technical expertise in office applications (e.g., Microsoft Office Suite, Adobe Acrobat) and shared document systems (e.g., SharePoint); familiarity with medical writing-specific tools / technology platforms preferred.
• Strong communication (oral, written, presentation) and project management skills.

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