Technical Writer (Medical)

US Remote

Job Description:

The Technical Writer is responsible for creating, editing, and maintaining high-quality scientific and technical documents and templates, used to design and support the conduct of clinical trials involving medical imaging. This role is also involved in identifying, evaluating, and implementing documentation and writing-support tools, including A.I.-based solutions, and supporting adoption by the members of the Science team.  In this role, the Technical Writer collaborates closely with subject matter experts (SME’s), including Scientists, Readers (radiologists), Clinical Operations, Imaging Operations, and Regulatory Affairs teams, to produce accurate, clear, and compliant documentation for a range of audiences.

Responsibilities & Accountabilities

  • Consistently perform duties within established Company Policies, Standard Operating Procedures (SOP’s), Work Instructions (WI’s), and Study Specific Procedures (SSP’s) in accordance with Good Clinical Practices (GCP’s)
  • Develop templates, and edit / author content, for clinical trial documents, including Imaging Charters (IC), Site Manuals (SM), and Project Specification Forms (PSF), including the development, maintenance, and application of document style guides
  • Collaborate with internal subject matter experts (SME’s), and external key opinion leaders (KOL’s), to gather complex technical and scientific information and translate it into clear, concise, and accurate documentation
  • Ensure all documentation adheres to regulatory guidelines (e.g., FDA), industry standards, and internal company templates and style guides
  • Manage the template lifecycle, including version control, approval, and archiving, using the company’s quality management system (QMS) and document control system
  • Identify and evaluate suitable AI (or other) software tools to enhance the efficiency, consistency, and accuracy of document creation while managing legal, ethical, and quality control challenges
  • Review existing workflows to identify areas with potential for AI augmentation; could include repetitive drafting, structuring technical manuals, standardizing reports, and other opportunities
  • Research and shortlist AI writing tools (ex. SciSpace, Jenni, Scite, Paperpal, Grammarly, and others) that may offer features relevant to Voiant documentation
  • Conduct evaluations of selected AI tools across different types of company documentation, to test their performance in areas such as content generation, editing, fact-checking, etc.
  • Determine how different AI tools would integrate with existing company software, including legacy systems, and evaluate the learning curve for employees
  • Quantify potential productivity gains (time savings) and cost reductions to establish a clear business case, and measure the return on investment (ROI), of a technology implementation
  • Address any questions or concerns that arise relating to data security, intellectual property, information accuracy (“hallucinations”), and potential bias in AI-generated text; includes establishing protocols and guidelines for responsible use
  • Support the development of an implementation roadmap, and execution of that rollout plan, by outlining a phased approach for integrating the most promising AI tool(s), along with a strategy for training and supporting the Science team to ensure successful adoption
  • Provide status and progress on assigned tasks in a timely manner to the Science team
  • Ability to work independently, and seek support when needed
  • Good analytical and problem-solving skills
  • Capable of handling confidential material and matters
  • Ability to take initiative to drive process improvements
  • Ability to manage multiple and varied tasks, with strict deadlines and prioritize workload whilst maintaining attention to detail
  • Exhibit and maintain a team approach with a positive attitude
  • Focus on timely delivery of high-quality results, with a proactive and flexible approach
  • Able to interact with confidence with internal and external partners

Education & Experience:

  • BA/BS is required; equivalent work experience may be substitutable
  • Minimum of 3 years’ experience in a technical writing role, or similar
  • Prior experience evaluating and working with tools used for writing support and documentation development, A.I. or other, including the development of an implementation plan
  • Excellent verbal and written communication skills, in the English language
  • Experience working within a quality management system (QMS)
  • Preferred: An understanding of medical and scientific terminology, particularly as it relates to medical imaging and clinical research

Schedule: Part-Time (10 hours a week)

Work Location: Remote

Candidates can send their CV to hr@voiantclinical.com. Please feel free to reach out to HR Talent & Culture with any questions.