Informed Consent Writer

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

📋 Description

• Review and comprehend protocol-specific designs, objectives, and study methodologies.

• Create study-specific informed consent documents utilizing established templates, protocol information, content libraries, glossaries (when relevant), and necessary risk language.

• Collaborate with protocol authors to ensure a thorough understanding of protocol specifics and the approval timeline.

• Draft, edit, and assess informed consent documents that embody the principles of health literacy.

• Oversee informed consent writing projects, including the design, planning, and preparation of documentation to support clinical development.

• Engage in clinical trial team meetings as appropriate to guarantee the timely submission of informed consent documents.

• Address and resolve issues related to informed consent documentation.

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

• Potential involvement in the training and mentoring of junior team members.

• Possible participation in initiatives aimed at enhancing medical writing processes and standards.

• Assist in the development, enhancement, and testing of tools as needed.

• Ensure adherence to company training requirements and time reporting protocols.

⛳️ Requirements

• Degree in life sciences.

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

• Knowledge of scientific concepts and health literacy.

• Familiarity with protocol structure and the essential information required for creating informed consent documents.

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

• Capability to prepare, with minimal oversight, a summary of a clinical trial's design, objectives, and activities for a lay audience, following established guidelines and regulatory requirements in a clear, concise, and health-literate manner.

• Knowledge of appropriate International Council on Harmonization (ICH) and regulatory guidelines related to Informed Consent.

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

• Experience with document management systems and managing workflows.

• Familiarity with collaborative authoring and review tools.

• Understanding of structured content management principles.

• Ability to thrive in a deadline-oriented environment and effectively work both independently and as part of a team.

• Complete fluency in reading and writing American English.

• Strong communication skills (email correspondence, meeting presentations).

• Effective time management, organizational, and interpersonal skills.

• Customer-centric approach.

• Robust project management capabilities.

🏝️ Benefits

• Various annual leave entitlements.

• A selection of health insurance options tailored to you and your family's requirements.

• Competitive retirement planning options to optimize savings and confidently prepare for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals dedicated to supporting you and your family's well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase programs, discounted gym memberships, subsidized travel passes, health assessments, among others.