Quality Control Specialist, Medical Writing

BeiGene

5d•$74,600 - $99,600

About The Position

The Quality Control Specialist coordinates and completes quality-control reviews of clinical and regulatory documents prepared or supported by Global Medical Writing. The role ensures documents are reviewed, copyedited, data-verified, and proofread to meet domestic and international regulatory submission requirements, internal standards, and project timelines. Documents include study reports, clinical study protocols and amendments, investigator’s brochures, clinical sections of INDs, NDAs, and MAAs, as well as manuscripts, abstracts, posters, briefing documents, health-authority responses, narratives, and other relevant materials. The position works with Medical Writers and other internal teams to deliver accurate, consistent, high-quality documents under tight timelines. The specialist contributes to team discussions and strategy with guidance from managers and mentors, builds knowledge through training, and applies effective communication, adaptability, innovation, and strategic awareness in their work. The role may be performed remotely or from any of BeOne’s global offices.

Requirements

Bachelor’s degree (BA/BS).
At least 1 year of relevant industry experience as a QC editor or specialist, medical writer, or technical copyeditor.
Demonstrated ability to communicate clearly, concisely, and effectively in English, both verbally and in writing.
Experience conducting medical-writing QC reviews of pharmaceutical regulatory documents, such as clinical study reports, protocols, and protocol amendments, or experience in technical editing in a related or similar industry.
Technical expertise in Microsoft Word, Outlook, Excel, PowerPoint, and Adobe Acrobat.
Proficiency navigating Microsoft Windows.
Ability to prioritize tasks, manage multiple projects, and meet tight timelines while maintaining quality.
Strong attention to detail, including consistency, grammar, syntax, and scientific accuracy.

Nice To Haves

Experience reviewing clinical sections of INDs, MAAs, and NDAs.
Familiarity with drug and biologics development and regulatory submission requirements defined in FDA regulations and ICH guidelines.
Master’s, PhD/PharmD, or another graduate-level degree.
Familiarity with SharePoint and Veeva Vault.

Responsibilities

Coordinate and complete assigned quality-control reviews of clinical and regulatory documents.
Perform quality checks before documents are approved, including cross-referencing, fact-checking, and general quality assessments.
Proofread for grammatical and formatting errors, hyperlink functionality, data-source verification, and accurate translation of data.
Ensure documents conform to Global Medical Writing conventions, processes, templates, and applicable regulatory guidelines.
Maintain consistency and scientific accuracy across related documents while making technical edits.
Prioritize multiple projects and complete high-quality reviews within tight timelines and changing priorities.
Adhere to QC timelines and communicate with Medical Writers about expectations, milestones, and deliverables.
Contribute to team direction and strategy discussions with guidance from managers and mentors.
Build effective partnerships with intradepartmental teams on QC reviews and projects.
Participate in training to expand knowledge of medical writing, relevant document types, medical terminology, and drug and biologics development.
Escalate questions or issues to appropriate stakeholders early, with guidance from a manager or mentor.
Apply new skills and techniques to improve time management, timeliness, and accuracy.
Provide feedback to teammates as requested, solicit and integrate constructive feedback, and share knowledge to support others’ learning.