[Hiring] Quality Control Specialist @BeiGene

Role 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
• Clinical sections of INDs, NDAs, MAAs, and other regulatory submission documents
• 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

This work can be done remotely or from any of BeOne’s global offices.

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

Requirements

• 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
• 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

Benefits

• Salary Range: $74,600.00 - $99,600.00 annually
• Participation in the annual bonus plan for Non-Commercial roles
• Incentive compensation plan for Commercial roles
• Opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness

Company Description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.