Clinical Technical Editor

Parexel FSP is looking to hire a Clinical Technical Editor! This is a remote anywhere in the United States and Canada.

Job Title: Clinical Technical Editor

Position Purpose: The Clinical Technical Editor is responsible for the quality control, formatting, technical editing, and tool support for the clinical regulatory writing portfolio composed of multiple therapeutic areas. The candidate will work within the client environment using client’s tools, systems, guidelines, checklists, and processes.

Organizational Relationships:

• Reports to ExecuPharm (EP) assigned Line Management with day-to-day direction from Client

• Liaises with cross-functional lines as appropriate

Primary Duties:

• Coordinate and perform 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

• Ensure documents comply with appropriate International Council on Harmonisation (ICH) standards, regulatory guidance, and company templates and processes

• Ensure consistent QC and good document practices are followed to ensure readiness for downstream stakeholders (eg, publishing teams)

• Proofread, review, edit, and confirm 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

• Work within appropriate document management systems to ensure security and version control is maintained

• Support the development, implementation, and periodic review of editorial management procedures

• Support tool enhancements, testing, and maintenance as applicable

• Support tools and processes for implementation of structured content management

• Work collaboratively with medical writers, regulatory publishers, and project team members to deliver high-quality clinical documentation in a timely manner • Support medical writers on the use of tools, technologies, and company templates to facilitate efficient and compliant document delivery

• Ensure compliance with company training and time reporting

• Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process-related training

• Adhere to EP and Client SOPs and processes

Skills and Education:

• Bachelor’s degree (English, Life Sciences)

• Minimum 2 years in editing and QC of scientific/clinical documentation in a pharmaceutical, biotech, clinical research, or related environment

• Complete fluency in reading and writing American English

• 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

• 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

• 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

• 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

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