• 招聘类型：社招
• 工作性质：全职

职位描述

Description

The Quality Control (QC) Specialist is responsible for the oversight, management, and coordination of all review, copyediting, and proofreading of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines. Clinical regulatory documents include, but are not limited to, study reports, clinical study protocols or amendments, investigator brochures, regulatory briefing documents, and the clinical sections of INDs, NDAs, MAAs and other regulatory submission documents. Other documents may include manuscripts, abstracts, posters, and presentations, as needed. The QC Specialist may also assist in the technical editing of clinical regulatory documents, as needed.

Essential Duties/ Responsibilities

• Works effectively with the Medical Writing group to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents
• Responsible for performing a quality check of clinical regulatory documents before approval

o Proofread documents for grammatical errors, formatting errors, hyperlink functionality, data source verification, and proper translation of data

o Perform cross-referencing, fact-checking, and general quality assessments of documents

• Manage timelines and communicate with Medical Writers to maintain awareness of expectations, milestones, and deliverables
• Review and edit documents written within BeiGene, as well as those authored externally
• Ensure compliance with Medical Writing conventions, processes, and applicable regulatory guidelines

任职条件

Education/Training

• BA/BS degree; PhD/PharmD in life sciences preferred
• At least 1-3 years of relevant industry experience as a QC editor/specialist, medical writer or copyeditor

Knowledge and Skills

• Demonstrated ability to communicate in clear, concise, and effective English and Chinese in both written and verbal forms
• Strong project management skills: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands
• Maintain consistent attention to detail (ie, to consistency, grammar, syntax, and scientific accuracy) while performing high volume, repetitive tasks
• Independently motivated with good problem-solving ability
• Excellent interpersonal skills; a team player
• Extensive experience in conducting QC review or copy editing of pharmaceutical industry regulatory documents such as clinical study reports, protocols, and protocol amendments; experience in reviewing or copy editing clinical sections of INDs, MAAs, and NDAs is a plus
• A thorough understanding of the key requirements for regulatory submissions as defined in FDA regulations and ICH guidelines
• Working knowledge of the development of drugs and biologics (ie, clinical study design, biostatistics, regulatory affairs, and medical terminology) preferred
• Ability to ensure reviewed documents comply with company and/or industry style guides and templates
• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint

职位要求

• 学历要求：本科及以上
• 工作经验：1年以上
• 外语要求：不需要

公司福利

• 五险一金 
• 晋升空间 
• 法定节假日