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ICON plc logo
ICON plc

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Informed Consent Writer

Content WriterContent WriterOtherRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

96 days ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

Informed Consent Writer

ICON plc

• 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

Job Requirements

  • Life sciences degree
  • 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience
  • Scientific Knowledge/Health Literacy
  • Understanding of protocol structure and knowledge of the relevant information needed to create an informed consent document
  • Understanding of clinical trial operations with specific knowledge of informed consent forms
  • Ability to prepare, with minimal supervision, a summary of a 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
  • 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 tool
  • Understanding of structured content management concepts
  • Flexibility in adapting to new tools and technology
  • Ability to work in a deadline-driven environment, and ability to work both independently and collaboratively with teams
  • 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.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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