Informed Consent Writer

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Drafting informed consent documents that communicate clinical trial information in accessible language.

• Engaging across various therapeutic areas utilizing client tools, systems, guidelines, templates, and processes.

• Partnering with protocol authors to ensure a thorough understanding of protocol details and the approval timeline.

• Composing, revising, and assessing informed consent documents.

• Overseeing informed consent writing projects, including the design, planning, and documentation preparation.

• Attending clinical trial team meetings to guarantee the timely delivery of informed consent document(s).

• Addressing document-related issues concerning informed consent.

• Providing expertise in the informed consent process and study-specific support to Global Clinical Trial Operations.

• Aiding in the orientation and mentoring of junior team members.

• Assisting in the development, enhancement, and testing of tools.

⛳️ Requirements

• Degree in life sciences.

• 3-5 years of relevant experience is preferred, including proven experience in translating scientific material for a general audience.

• Knowledge of scientific concepts/health literacy.

• Familiarity with protocol structure and the relevant information necessary for creating an informed consent document.

• Understanding of clinical trial operations, with specific knowledge of informed consent forms.

• Ability to summarize a clinical trial design, objectives, and activities for a lay audience in accordance with guidelines and regulations.

• Awareness of appropriate International Council on Harmonization (ICH) and regulatory guidance related to informed consent.

• Proficiency in MS Office (Word, Excel, Project) and Adobe Acrobat.

• Experience with document management systems and workflow management.

• Experience in collaborative authoring and review tools.

• Understanding of structured content management principles.

• Adaptability to new tools and technologies.

• Excellent communication skills for emails and meeting presentations.

• Strong time management, organizational, and interpersonal skills.

• Robust project management capabilities.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.