Quality Control Specialist, Medical Writing
Core
Ensuring accuracy, consistency, and quality of clinical and regulatory documents throughout the medical writing process.
Role type
Quality Control Specialist, Medical Writing
Builds
Clinical study reports, protocols, investigator's brochures, INDs, NDAs, MAAs, manuscripts, abstracts, posters, briefing documents, health authority responses, and narratives.
Domain
Pharmaceutical/Biologics development and regulatory submissions
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Scientific review, technical editing, proofreading, data verification, cross-referencing, fact-checking, grammar and syntax review, formatting consistency, regulatory guideline adherence, project prioritization, stakeholder coordination
Preferred skills
Graduate-level degree (Master's, PhD, PharmD), experience with clinical sections of INDs/NDAs/MAAs, familiarity with FDA regulations and ICH guidelines, SharePoint and Veeva Vault proficiency
Technologies
Microsoft Word, Outlook, Excel, PowerPoint, Adobe Acrobat, Microsoft Windows, SharePoint, Veeva Vault
Responsibilities
Conduct quality control reviews of clinical and regulatory documents before final approval; Perform cross-referencing, fact-checking, data verification, and proofreading across medical writing deliverables; Review documents for grammar, syntax, formatting, consistency, and source data accuracy; Ensure documents follow established medical writing conventions and regulatory guidelines; Maintain scientific accuracy and consistency while meeting project timelines; Coordinate with medical writers and stakeholders on expectations and milestones; Participate in training on medical writing, terminology, and regulatory requirements.
Seniority
Entry-level to Mid-level, hands-on IC
