Quality Control Specialist, Medical Writing

General Description

The QC Specialist is responsible for coordinating and completing assigned QC reviews, ensuring that clinical and regulatory documents undergo review, copyediting, data verification, and proofreading in a manner that conforms to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.

Clinical and regulatory documents include study reports, clinical study protocols or amendments, investigator's brochures, and the clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, briefing documents, responses to health authorities, narratives, and any other documents authored or supported by Global Medical Writing that require a QC review.

Essential Functions of the Job

Document Review and Editing: Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents.

• Responsible for performing a quality check of clinical and regulatory documents before approval.
• Performs cross-referencing, fact-checking, and general quality assessments of documents.
• Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data.
• Ensures compliance with Global Medical Writing conventions, processes, templates and applicable regulatory guidelines.
• Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits.

Project and Process Management: Ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality QC reviews according to tight timelines and shifting priorities/demands.

• Adheres to QC timelines and communicates with Medical Writers to maintain awareness of expectations, milestones, and deliverables.
• Contributes to team direction and strategy discussions, with guidance from managers and mentors.

Influence and Training: Builds effective partnerships with all intradepartmental teams when collaborating on QC reviews and projects.

• Engages in trainings that will increase knowledge of medical writing, the types of documents in the scope of the Global Medical Writing team, medical terminology, and the development of drugs and biologics.

Qualifications

• Demonstrated ability to communicate in clear, concise, and effective English (both written and verbal).
• Experience in conducting medical writing QC reviews of pharmaceutical industry regulatory documents (such as clinical study reports, protocols, and protocol amendments) or experience in technical editing in a related or similar industry; experience in reviewing clinical sections of INDs, MAAs, and NDAs is a plus.
• Familiarity with the general process of drug/biologics development as well as the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines is preferred.

Other Qualifications

• Effective Communication: Explains own work clearly. Able to escalate questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor.
• Embracing Change: Always seeking and open to new opportunities and changes.
• Creating Innovation: Demonstrates openness to innovation and applies new ways of working to improve time management, timeliness, and accuracy.
• Thinking Strategically: Understands key concepts related to own work with guidance from manager/mentor.
• Mentoring: Provides specific feedback to others within own team as requested.
• Computer Skills: Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat. Proficiency in navigating Microsoft Windows. Familiarity with SharePoint and Veeva Vault is a plus.

Education Required

BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus. At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor.