Clinical Technical Editor - FSP
Location:
Canada, Remote
Category: Medical Writing
Job ID: N/A
About This Role:
Parexel FSP is seeking a Clinical Technical Editor to join its team. This remote position requires expertise in quality control, formatting, and technical editing of clinical regulatory documents across multiple therapeutic areas. The Clinical Technical Editor ensures that clinical documents meet the highest standards of accuracy, consistency, and compliance with international and regulatory guidelines. The role involves collaborating with medical writers, regulatory publishers, and cross-functional teams to deliver high-quality documents that support clinical trials and regulatory submissions.
Key Responsibilities:
Document Quality Control:
Coordinate and perform quality control (QC) of clinical documents to ensure data consistency and document integrity.
Ensure compliance with International Council on Harmonisation (ICH) standards, regulatory guidance, and company templates.
Perform proofreading, reviewing, and editing to verify completeness, accuracy, grammar, and format standards.
Maintain version control and document security within document management systems.
Support editorial procedures and tool enhancements, ensuring alignment with company standards.
Communication and Collaboration:
Collaborate with medical writers, regulatory publishers, and project teams to deliver high-quality clinical documentation on time.
Provide support to medical writers on tools, technologies, and templates to ensure efficient and compliant document delivery.
Work with cross-functional teams and vendors to ensure smooth communication and document flow.
Compliance with Parexel Standards:
Comply with required training and submission processes.
Maintain accurate timesheets and expense reports.
Stay updated on Parexel processes, ICH-GCPs, and other applicable regulatory requirements.
Skills:
Experience in QC of clinical documentation, including clinical protocols, informed consent forms, study reports, and more.
Advanced skills in Word and Adobe Acrobat.
Ability to adapt to new tools and technologies.
Excellent writing, editing, and communication skills.
Effective time management and organizational skills.
Fluency in American English, both written and spoken.
Customer-focused with the ability to work independently in a fast-paced environment.
Knowledge and Experience:
Minimum 2 years of experience in editing and QC of clinical/scientific documents in a pharmaceutical or clinical research setting.
Knowledge of ICH and regulatory guidelines for clinical documentation.
Familiarity with Study Data Tabulation Model (SDTM) and data reconciliation.
Experience in Excel and document management systems, with macro writing skills preferred.
Experience with collaborative authoring and review tools.
Education:
Bachelor’s Degree or equivalent (Life Sciences preferred).
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