Sr. QC Editor & Publisher (W2 Consultant)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Senior Quality Control (QC) Editor position is responsible for performing quality reviews and editing of complex clinical documents, regulatory submissions, publications, and other related documents ensuring accurate high-quality deliverables. The Senior QC Editor is also responsible for the mentoring of QC team members as well as being a key driver for process improvement and development.

Essential Functions: 

• Perform detailed QC review of clinical and regulatory documents, tables, publications, annual reports, literature summaries, submission sections, internal documents, etc.
• Verify content to ensure accuracy and integrity of all factual statements within document text compared to post-text sources cited and interpret clinical data I literature as needed to perform QC duties.
• Copyedit documents to correct and streamline grammar, spelling, punctuation, style, and format, while troubleshooting functionality and presentation of documents and templates.
• Lead 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.
• Work on special QC projects and initiatives to help drive consistency and performance of the QC team regarding best processes I 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.
• Train new hires and junior colleagues within the QC group and function as a mentor.
• Provide QC training to members of the Global Medical Writing team in aspects relative to their roles.
• Act as a primary backup to team members during peak volume periods or to provide coverage.
• Represent the QC group on study teams and on cross-functional project teams as needed.
• Bring issues and potential concerns to the attention of the line manager / client oversight manager and propose possible solutions for consideration by the management team.
• Ensure accurate and on time billing of time to projects and notify line manager if time entry codes are not correct.
• Strive to complete medical writing deliverables on time and within budget.
• Other duties as assigned.

Necessary Skills and Abilities:          

• Pharmaceutical and / or Biotech background strongly pref erred.
• 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 the American Medical Association (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).