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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 Redacteur des formulaires de consentement eclaire (Informed Consent Writer - ICW) est responsable de la redaction de documents de consentement eclaire presentant les informations relatives a un essai clinique dans un langage accessible et comprehensible, afin d'aider les candidats a prendre une decision eclairee concernant leur participation a l'essai.
L'ICW travaillera sur plusieurs aires therapeutiques en utilisant les outils, systemes, lignes directrices, modeles et processus de client.
L'ICW devra demontrer les competences suivantes :

• Comprehension de la structure des protocoles et connaissance des informations pertinentes necessaires a la creation d'un document de consentement eclaire

• Comprehension des operations des essais cliniques, avec une connaissance specifique des formulaires de consentement eclaire

• Capacite a preparer, avec une supervision minimale, un resume du design, des objectifs et des activites d'un essai clinique destine a un public non specialiste, en utilisant les lignes directrices etablies et les reglementations gouvernementales, dans un format clair, concis et adapte a la litteratie en sante

• Connaissance des lignes directrices pertinentes de l'International Council on Harmonization (ICH) et des exigences reglementaires relatives au consentement eclaire

• Expertise technique des outils MS Office (Word, Excel, Project) et d'Adobe Acrobat

• Experience des systemes de gestion documentaire et de la gestion des flux de travail

• Experience des outils collaboratifs de redaction et de relecture

• Comprehension des concepts de gestion de contenu structure

• Flexibilite et capacite d'adaptation a de nouveaux outils et technologies

• Capacite a travailler dans un environnement soumis a des delais stricts, de maniere autonome et en collaboration avec des equipes

• Maitrise complete de la lecture et de l'ecriture en anglais americain

• Excellentes competences en communication (reponses par e-mail, presentations en reunion)

• Solides competences en gestion du temps, organisationnelles et interpersonnelles

• Orientation client

• Fortes competences en gestion de projet

• Diplome en sciences de la vie

• 3 a 5 ans d'experience pertinente souhaitee, incluant une experience demontree dans la traduction de contenus scientifiques pour un public non specialise

• Lire et comprendre le design, les objectifs et les procedures specifiques aux protocoles

• Rediger des documents de consentement eclaire specifiques aux etudes en utilisant des modeles etablis, les informations issues des protocoles, des bibliotheques de contenu et des glossaires (le cas echeant), ainsi que le langage requis relatif aux risques

• Collaborer avec les auteurs de protocoles afin d'assurer une comprehension complete des details du protocole et du calendrier d'approbation

• Rediger, editer et relire les documents de consentement eclaire conformement aux principes de la litteratie en sante

• Gerer les projets de redaction de consentement eclaire, incluant la conception, la planification et la preparation de la documentation en soutien au developpement clinique

• Participer, le cas echeant, aux reunions des equipes d'essais cliniques afin d'assurer la livraison dans les delais des documents de consentement eclaire

• Resoudre les problematiques documentaires liees au consentement eclaire

• Apporter un soutien aux Operations Mondiales des Essais Cliniques grace a son expertise des processus de consentement eclaire et a un support specifique aux etudes

• Participer eventuellement a l'integration et au coaching des membres juniors de l'equipe

• Participer eventuellement a des initiatives visant a ameliorer les processus et normes de redaction medicale

• Soutenir le developpement, l'amelioration et les tests des outils, le cas echeant

• 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 requesthere.

Are you a current ICON Employee? Please click here to apply