[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

• Works effectively within the Global Medical Writing department to produce high-quality, scientifically accurate documents under strict timelines
• Responsible for performing a quality check of clinical and regulatory documents before approval
• Performs cross-referencing, fact-checking, and general quality assessments of documents
• Proofreads documents for grammatical and formatting errors, hyperlink functionality, data source verification, and proper translation of data
• Ensures compliance with Global Medical Writing conventions, processes, templates, and applicable regulatory guidelines
• Maintains strong attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing technical edits
• 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
• Contributes to team direction and strategy discussions, with guidance from managers and mentors
• 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

Other Qualifications

• Effective Communication: Explains own work clearly and escalates questions/issues to appropriate stakeholders at an early stage, with guidance from manager/mentor
• Embracing Change: Always seeking and open to new opportunities and changes; copes well with change and new challenges with guidance from manager/mentor
• Creating Innovation: Demonstrates openness to innovation and applies new ways of working (eg, skills or techniques) in own work to improve time management, timeliness, and accuracy
• Thinking Strategically: Understands key concepts (eg, strategic review, lean writing) related to own work with guidance from manager/mentor
• Mentoring: Provides specific feedback to others within own team as requested; solicits feedback and accepts and integrates changes from constructive criticism
• Computer Skills: Technical expertise in Microsoft Word, Microsoft Outlook, Excel, PowerPoint, and Adobe Acrobat; proficiency in navigating Microsoft Windows; familiarity with SharePoint and Veeva Vault is a plus

Education Required

• BA/BS degree; Masters, PhD/PharmD, or other graduate-level degree is a plus
• At least 1 year of relevant industry experience as a QC editor/specialist, medical writer, or technical copyeditor

Salary Range

$74,600.00 - $99,600.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness
• All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan

Equal Opportunity Employer

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.