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The Informed Consent Writer is responsible for creating health-literate informed consent documents for clinical trials across various therapeutic areas. This includes collaborating with protocol authors and managing the design and planning of documentation to ensure timely delivery and regulatory compliance.
Requirements summary
Candidates should possess a life sciences degree and preferably 3-5 years of experience translating scientific material for lay audiences. Proficiency in MS Office, Adobe Acrobat, and a strong understanding of ICH and regulatory guidance for informed consent are required.
Informed Consent Writer- Remote 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.
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 client 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.
Benefits
Learning and development opportunities
Medical coverage
Dental coverage
Vision coverage
Competitive base salary
Life assurance
Disability coverage
Wellbeing resources
Employee assistance programmes
Performance related incentives
Retirement and pension plans
L’ICW travaillera sur plusieurs aires thérapeutiques en utilisant les outils, systèmes, lignes directrices, modèles et processus de client.
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 Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility ICON is an equal opportunity employer.
We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
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.
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