Clinical Technical Editor- FSP

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

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

Harmonisation (ICH) standards, regulatory guidance, and company

templates and processes

readiness for downstream stakeholders (eg, publishing teams)

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

and version control is maintained

management procedures

management

Communication and Collaboration

team members to deliver high-quality clinical documentation in a timely

manner

templates to facilitate efficient and compliant document delivery

Compliance with Parexel Standards

ICH-GCPs, and other applicable requirements

Skills :

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

Knowledge and Experience :

biotech, clinical research, or related environment

the data to reconcile data back to source

troubleshooting user errors

Education :

LI-SS1

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.