ProPharma Group

Senior QC Editor

ProPharma Group • $80K — $95K *
Western Springs, IL 60558In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Pharmaceutical and/or Biotech experience preferred.
  • Strong skills in copyediting and data accuracy.
  • Excellent problem-solving abilities.
  • Familiar with FDA, EU, ICH regulations, and ISO standards.
  • Knowledgeable in AMA Manual of Style.
  • Independently motivated with proactive work ethic.
  • Fluent in English with strong written and verbal skills.
  • Proficient in Microsoft Office and Adobe/PDF software.

Responsibilities

  • Conduct detailed QC reviews of clinical and regulatory documents.
  • Verify content for accuracy and interpret clinical data as needed.
  • Copyedit documents to enhance clarity, grammar, and presentation.
  • Lead resolution of discrepancies within documents and archive results.
  • Manage multiple projects and prioritize tasks effectively.
  • Work on special QC initiatives to improve team performance.
  • Contribute to the development of process improvement tools.
  • Train new hires and mentor junior QC colleagues.
  • Provide QC training for the global medical writing team.
  • Act as a backup during peak periods and represent the QC group on project teams.

Benefits

  • Remote work flexibility with an emphasis on hybrid collaboration.
  • Opportunities for professional development and mentorship.
Full Job Description
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, Outlook) and Adobe/PDF software.


  • Exceptional written and oral communication skills (reading, writing, editing, team communication).


Educational Requirements:

  • Bachelor's degree in relevant field of study.


Experience Requirements:

  • At least 3 years of QC/editing experience in the pharmaceutical industry.


Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

About ProPharma Group

ProPharma Group is a pharmaceutical consulting company that provides regulatory compliance, pharmacovigilance, and medical information services to clients in the healthcare industry. The company was founded in 2001 and is headquartered in Shawnee Mission, Kansas. ProPharma Group offers a range of services, including clinical trial support, quality assurance, and validation services. The company has worked with clients in a variety of industries, including pharmaceuticals, biotechnology, and medical devices.
Learn more about ProPharma Group
Size
500 employees
Industry
Pharmaceuticals & Biotech
Net Income
$5 million
Founded
2001
5 Year Trend
+30%
Revenue
$50 million
* Ladders Estimates

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