北京招聘

?    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
职位要求：
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
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

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。