Senior QC Editor

Essential Functions: 

• Performs detailed QC review of clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, internal documents, etc. 

• Verifies content to ensure accuracy and integrity of all factual statements within document text compared to post-text sources cited and interprets clinical data/literature as needed to perform QC duties. 

• Copyedits documents to correct and streamline grammar, spelling, punctuation, style, and format, while troubleshooting functionality and presentation of documents and templates. 

• Leads resolution of discrepant findings within documents, including documenting actions, verifying implementation of findings, and archiving results. 

• Project management - ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities and demands. 

• Works on special QC projects and initiatives to help drive consistency and performance of the QC team regarding best processes/practices, adherence to style guides, and sponsor expectations. 

• Key contributor to the development of process improvement tools and the development or revision of internal policies and procedures affecting QC work and processes. 

• Trains new hires and junior colleagues within the QC group and functions as a mentor. 

• Provides QC training to members of the global medical writing team in aspects relative to their roles. 

• Acts as a primary backup to team members during peak volume periods or to provide coverage. 

• Represents the QC group on study teams and on cross-functional project teams as needed. 

• Other duties as assigned. 

Necessary Skills and Abilities: 

• Pharmaceutical and/or Biotech background strongly preferred. 

• Strong copyediting, data integrity review, accuracy, and problem-solving skills. 

• Exceptional time management skills and attention to detail. 

• Knowledge of FDA and EU requirements, ICH regulations, and ISO standards as applicable to regulatory documents. 

• Possesses knowledge of AMA Manual of Style. 

• Independently motivated and proactive. 

• Ability to work with minimal supervision on multiple assignments with set deadlines. 

• Excellent use of English language (read, write, and speak fluent English). 

• Expertise in Microsoft Office (Word, Excel, PowerPoint, Outloo