Quality Control Specialist, Medical Writing

🕒 September 18

🇺🇸 United States – Remote

💵 $74.6k - $99.6k / year

⏰ Full Time

🟢 Junior

✏️ Content Writer

👻 Ghost score 11%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Coordinate and complete assigned quality-control reviews of clinical and regulatory documents • Perform copyediting, data verification, proofreading, cross-referencing, fact-checking, 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 • Verify grammar, formatting, hyperlinks, data sources, translations, scientific accuracy, and consistency between related documents • Ensure compliance with Global Medical Writing conventions, processes, templates, and regulatory guidelines • Prioritize multiple projects and complete QC reviews within tight timelines • Adhere to QC timelines and communicate with Medical Writers regarding expectations, milestones, and deliverables • Contribute to team direction and strategy discussions • Collaborate with intradepartmental teams on QC reviews and projects • Participate in training related to medical writing, medical terminology, drug and biologics development, and document types

🎯 Requirements

• Clear, concise, and effective English communication, written and verbal • Experience conducting medical writing QC reviews of pharmaceutical industry regulatory documents or technical editing in a related industry • Familiarity with drug/biologics development processes 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 • BA/BS degree • At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor • Familiarity with SharePoint and Veeva Vault is a plus

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Remote work option • Opportunity to work from any of BeOne’s global offices

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