Informed Consent Writer

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 Merck tools, systems, guidelines, templates, and processes.

Organizational Relationships:

• Reports to Parexel (PXL) assigned Line Management with day-to-day direction from Client
• Liaises with cross-functional lines/vendors, as appropriate

Primary Responsibilities:

• Read and understand protocol-specific design, objectives, and study procedures
• With minimal guidance from senior members of writing staff, prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
• Work collaboratively 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 to deliver high-quality clinical documentation in a timely manner
• Comfortable following directions, templates, and structured processes; and coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
• Participate, when appropriate, in clinical trial team meetings to ensure timely and consistent 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
• Complete training assigned by Client and/or (functional service provider) FSP, including general training requirements, Policies, Standard Operating Procedures (SOPs), system, and process-related training
• Adhere to applicable Policies, SOPs, and processes
• Demonstrate commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values

Education and Certification:

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

Skills and Experience:

• 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 Harmonisation (ICH) standards and regulatory guidance and company templates and processes 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 tools
• 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
• Excellent communication skills (email responses, meeting presentations)
• Effective time management, organizational, and interpersonal skills
• Customer focus
• Strong project management skills

Language Skills:

• Complete fluency in reading and writing American English