Clinical Technical Editor- FSP

Parexel FSP is looking for a Clinical Technical Editor!

This role is remote and can be located anywhere in the US or Canada!

Job Purpose:
The clinical technical editor (CTE) performs the quality control, formatting, technical editing, and tool support for the clinical regulatory writing portfolio composed of multiple therapeutic areas.

Key Accountabilities:
May include but not limited to the following:

1. Document Quality Control
   • Coordinates and performs quality control (QC) of clinical documents to ensure data consistency and document integrity, consistency of text with internal document data displays as well as external reference sources
   • Ensures documents comply with appropriate International Council on Harmonisation (ICH) standards, regulatory guidance, and company templates and processes
   • Ensures consistent QC and good document practices are followed to ensure readiness for downstream stakeholders (eg, publishing teams)
   • Proofreads, reviews, edits, and confirms data against sources to verify:
   o Completeness and accuracy of information
   o Accurate use of grammar and style
   o Application of format standards for electronic documents
   o Compliance with submission ready standards
   • Works within appropriate document management systems to ensure security and version control is maintained
   • Supports the development, implementation, and periodic review of editorial management procedures
   • Supports tool enhancements, testing, and maintenance as applicable
   • Supports tools and processes for implementation of structured content management
2. Communication and Collaboration
   • Works collaboratively with medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner
   • Supports medical writers on the use of tools, technologies, and company templates to facilitate efficient and compliant document delivery
   • Liaises with cross-functional lines/vendors, as appropriate
3. Compliance with Parexel Standards
   • Complies with required training curriculum
   • Completes timesheets accurately as required
   • Submits expense reports as required
   • Updates CV as required
   • Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements

Skills:
• Ability to perform QC for clinical documentation that includes, but is not limited to, clinical protocols, investigator brochures, informed consent forms, clinical study reports (including administrative appendices), patient narratives, and clinical modules of the common technical document in multiple therapeutic areas
• Advanced Word and Adobe Acrobat skills
• Flexibility in adapting to new tools and technology
• Writing and editing skills following defined processes and templates
• Good communication skills (email responses, meeting presentations)
• Effective time management, organizational, and interpersonal skills
• Customer focused
• Ability to work independently in a fast-paced environment
• Complete fluency in reading and writing American English

Knowledge and Experience:
• Minimum 2 years in editing and QC of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment
• Understanding of appropriate ICH and regulatory guidance pertaining to clinical documents
• Understanding of Study Data Tabulation Model (SDTM) data structures for purposes of navigating the data to reconcile data back to source
• Experience working in Excel workbooks; macro writing capabilities preferred
• Experience working in document management systems; capable of managing workflows and troubleshooting user errors
• Experience with collaborative authoring and review tools

Education:
• Bachelor’s Degree or equivalent (Life Science preferred)