Clinical Technical Editor- FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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:

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

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

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)

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.