MW Operations Document Specialist (Contract)
MW Operations Document Specialist (Contract)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
The incumbent(s) will report to the Manager, Medical Writing Operations. The incumbent will be responsible for ensuring the quality of technical documents by conducting quality control (QC) review and GLP-compliant final quality audits for all applicable documents authored by Oncology Scientific Writing and Communications. Using a checklist or a work instruction, checking document and data compliance to cGxPs, internal SOPs for design control, internal style guides, spelling and grammar, and document-to-document consistency are essential tasks of this role. The incumbent will also be responsible for routing checked documents through an electronic Quality Management System.
This is a part time, on-going contract position requiring approximately 20 hours of work per week.
Position Overview:
Incorporation of Tables, Figures, and Listings received from Biostats or other functions
TFL incorporation into reports, ensuring appropriate pagination, styles, formatting and alignment
Document routing:
Authors change orders, including impact assessments, in compliance with internal design control SOPs
Routes documents through ArcherDX electronic Quality Management System
Communicates with Manager, Medical Writing Operations to resolve routing issues
Ensures file format and nomenclature match design control SOPs, including renaming files, creating PDFs, and combining documents into single files
Required Qualifications:
- Proficiency with Word, including formatting, cross-reference tools, change tracking, and document comparison
- Familiarity with Excel, including importing .csv and .tsv files
- Familiarity with Adobe Acrobat, including combining pdfs
- Verbal and written communication skills, including willingness to ask coworkers for clarification and providing QC findings to coworkers and manager
- Detail-oriented and willing to consistently follow checklists / job instructions
- Capable of working collaboratively from a remote work environment
- Bachelor’s degree (BA/BS) required or equivalent experience.
- 2-4 years relevant pharmaceutical industry experience in medical writing, quality, or related area such as regulatory or product support.
- Experience in quality review of regulatory documents
Additional expertise, as noted below, is a plus:
- Experience with drafting, editing, and/or quality control checking technical documentation
- Experience with eQMS systems, particularly Arena
- Experience with in vitro / Companion Diagnostics