Medical Writing Operations QC Reviewer (Contract)

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.

QC and final quality audits:

• Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs)
• Follows a checklist to ensure document compliance to cGxP.
• Communicates document discrepancies, comments, and required changes with Manager, Medical Writing Operations

Document formatting and consistency:

• Checks document formatting to ensure consistency with internal style guide, other published documents
• Reviews spelling, grammar, consistent usage of acronyms
• Checks document internal and cross-references

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