Informed Consent Writer

PXL FSP has an exciting opportunity for a medical writer with experience writing ICFs!

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 LiteracyUnderstanding of protocol structure and knowledge of the relevant information needed to create an informed consent documentUnderstanding of clinical trial operations with specific knowledge of informed consent formsAbility 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 formatUnderstanding of appropriate International Council on Harmonisation (ICH) and regulatory guidance pertaining to Informed Consent

Technology SkillsTechnical expertise in MS Office (Word, Excel, Project) and Adobe AcrobatExperience working in document management systems; managing workflowsExperience with collaborative authoring and review toolUnderstanding of structured content management conceptsFlexibility in adapting to new tools and technology

OtherAbility to work in a deadline-driven environment, and ability to work both independently and collaboratively with teamsComplete fluency in reading and writing American EnglishExcellent communication skills (email responses, meeting presentations)Effective time management, organizational, and interpersonal skillsCustomer focusStrong project management skills

EducationLife sciences degree3-5 years of relevant experience preferred, including demonstrated experience translating scientific material for a lay audience

ResponsibilitiesRead and understand protocol-specific design, objectives, and study proceduresPrepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk languageWork with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timelineWrite, edit and review informed consent documents that reflect the principles of health literacyManage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical developmentParticipate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)Resolve document issues relating to informed consentSupport Global Clinical Trial Operations with informed consent process expertise and study specific supportPossible participation in the orientation and coaching of junior team membersPossible participation in initiatives to improve medical writing processes and standardsSupport tool development, enhancements, and testing, as applicableEnsure compliance with company training and time reporting

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