Quality Control Specialist, Medical Writing

BeOne Medicines

. Coordinate and complete assigned quality-control reviews of clinical and regulatory documents .

Posted 9/18/2026full-timeRemote • United StatesJunior💰 $74,600 - $99,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality control reviews of clinical and regulatory documents, ensuring compliance with internal standards and regulatory guidelines. Proficient in medical writing, copyediting, and effective communication within cross-functional teams.

Highest-signal resume keywords

Quality Control ReviewsMedical WritingRegulatory GuidelinesTechnical EditingMicrosoft Office Suite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CopyeditingProofreadingData VerificationFact-CheckingQuality AssessmentDocument ReviewScientific AccuracyFormattingCross-ReferencingGrammar

Soft Skills

Effective CommunicationTeam CollaborationProject PrioritizationAdaptabilityStrategic Contribution

Tools & Technologies

Microsoft WordMicrosoft OutlookMicrosoft ExcelMicrosoft PowerPointAdobe AcrobatSharePointVeeva Vault

Industry Keywords

Clinical Study ProtocolsINDsNDAsMAAsHealth-Authority ResponsesDrug DevelopmentBiologics DevelopmentFDA RegulationsICH GuidelinesPharmaceutical Industry

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Coordinate and complete assigned quality-control reviews of clinical and regulatory documents
Perform copyediting, proofreading, cross-referencing, fact-checking, data verification, and general quality assessments
Review study reports, clinical study protocols and amendments, investigator’s brochures, INDs, NDAs, MAAs, manuscripts, abstracts, posters, briefing documents, health-authority responses, and narratives
Ensure documents meet internal standards, Global Medical Writing conventions, applicable regulatory guidelines, and project timelines
Maintain consistency between related documents and verify hyperlinks, data sources, formatting, grammar, syntax, and scientific accuracy
Prioritize multiple projects and complete QC reviews amid tight timelines and shifting priorities
Communicate with Medical Writers regarding expectations, milestones, and deliverables
Contribute to team direction and strategy discussions
Build partnerships with intradepartmental teams
Participate in training related to medical writing, medical terminology, drug and biologics development, and document types

Requirements

What you’ll need

Clear, concise, and effective English communication skills, written and verbal
Experience conducting medical writing QC reviews of pharmaceutical industry regulatory documents or technical editing in a related/similar industry
Familiarity with the general process of drug/biologics development and regulatory submission requirements under FDA regulations and ICH guidelines is preferred
Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat
Proficiency navigating Microsoft Windows
Familiarity with SharePoint and Veeva Vault is a plus
BA/BS degree
At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for commercial roles
Discretionary equity awards
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness benefits
Remote work or work from any of BeOne’s global offices