Informed Consent Writer

ICON plc

16d • Remote

About The Position

Informed Consent Writer- Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development The Informed Consent Writer (ICW) is responsible for preparing informed consent documents that disclose information about a clinical trial using health literate language to help a candidate make an informed decision about trial participation. The ICW will work across multiple therapeutic areas using MSD tools, systems, guidelines, templates, and processes. The ICW is to demonstrate the following skills: 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 Technology Skills 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 Other 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 Education Life sciences degree 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience Responsibilities 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 Le Rédacteur des formulaires de consentement éclairé (Informed Consent Writer – ICW) est responsable de la rédaction de documents de consentement éclairé présentant les informations relatives à un essai clinique dans un langage accessible et compréhensible, afin d’aider les candidats à prendre une décision éclairée concernant leur participation à l’essai. L’ICW travaillera sur plusieurs aires thérapeutiques en utilisant les outils, systèmes, lignes directrices, modèles et processus de MSD. L’ICW devra démontrer les compétences suivantes : Connaissances scientifiques / Littératie en santé Compréhension de la structure des protocoles et connaissance des informations pertinentes nécessaires à la création d’un document de consentement éclairé Compréhension des opérations des essais cliniques, avec une connaissance spécifique des formulaires de consentement éclairé Capacité à préparer, avec une supervision minimale, un résumé du design, des objectifs et des activités d’un essai clinique destiné à un public non spécialiste, en utilisant les lignes directrices établies et les réglementations gouvernementales, dans un format clair, concis et adapté à la littératie en santé Connaissance des lignes directrices pertinentes de l’International Council on Harmonization (ICH) et des exigences réglementaires relatives au consentement éclairé Compétences technologiques Expertise technique des outils MS Office (Word, Excel, Project) et d’Adobe Acrobat Expérience des systèmes de gestion documentaire et de la gestion des flux de travail Expérience des outils collaboratifs de rédaction et de relecture Compréhension des concepts de gestion de contenu structuré Flexibilité et capacité d’adaptation à de nouveaux outils et technologies Autres compétences Capacité à travailler dans un environnement soumis à des délais stricts, de manière autonome et en collaboration avec des équipes Maîtrise complète de la lecture et de l’écriture en anglais américain Excellentes compétences en communication (réponses par e-mail, présentations en réunion) Solides compétences en gestion du temps, organisationnelles et interpersonnelles Orientation client Fortes compétences en gestion de projet Formation Diplôme en sciences de la vie 3 à 5 ans d’expérience pertinente souhaitée, incluant une expérience démontrée dans la traduction de contenus scientifiques pour un public non spécialisé Responsabilités Lire et comprendre le design, les objectifs et les procédures spécifiques aux protocoles Rédiger des documents de consentement éclairé spécifiques aux études en utilisant des modèles établis, les informations issues des protocoles, des bibliothèques de contenu et des glossaires (le cas échéant), ainsi que le langage requis relatif aux risques Collaborer avec les auteurs de protocoles afin d’assurer une compréhension complète des détails du protocole et du calendrier d’approbation Rédiger, éditer et relire les documents de consentement éclairé conformément aux principes de la littératie en santé Gérer les projets de rédaction de consentement éclairé, incluant la conception, la planification et la préparation de la documentation en soutien au développement clinique Participer, le cas échéant, aux réunions des équipes d’essais cliniques afin d’assurer la livraison dans les délais des documents de consentement éclairé Résoudre les problématiques documentaires liées au consentement éclairé Apporter un soutien aux Opérations Mondiales des Essais Cliniques grâce à son expertise des processus de consentement éclairé et à un support spécifique aux études Participer éventuellement à l’intégration et au coaching des membres juniors de l’équipe Participer éventuellement à des initiatives visant à améliorer les processus et normes de rédaction médicale Soutenir le développement, l’amélioration et les tests des outils, le cas échéant Veiller au respect des exigences de formation de l’entreprise et au suivi du temps de travail What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: 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. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply ICON is an award-winning workplace that enables you to make a difference to patients’ lives by being part of a world-class clinical research organisation that helps deliver new medicines & medical devices that are benefitting patients worldwide. You are also part of a diverse company that cares about our world and is dedicated to conducting business more sustainably and supporting the communities in which we live. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. Didn’t find the role you were looking for? Even if the perfect role isn’t available right now, we’re always excited to connect with talented individuals. Register to our Talent Community to receive updates on roles that align with your career goals.

Requirements

• 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
• Life sciences degree
• 3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience

Responsibilities

• 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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees