Specialist/Sr Specialist, Medical Writing

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 2年工作经验 | 硕士

2020-05-20发布

招聘人数:1人

100000-250000元/年

申请职位

职位信息

Position Summary Closely working with medical writers and clinical physicians to contribute to clinical study related medical writing activities to meet customer’s clinical trial project needs. He / she will carry out day-to-day hands-on work and maintain good medical writing relationships with project related stakeholders internally and externally. Key Responsibilities - To work directly with medical writing manager, clinical physician, biostatistician, programmers, or relevant parties involved in all medical writing activities. - To carry out hands-on medical writing in accordance with company SOPs and GCP. - To participate in the discussion and drafting the clinical development plan and editing - To prioritize and plan workload to a high standard - To work directly with medical team and clinical research physician to carry out clinical study related medical writing including IB, study synopsis, protocol, CSR, clinical document translation. - To search product, target indication with market analysis and report - To be involved in the preparations on the documentation for regulatory submissions (e.g. investigator brochures, protocols, and CSR). - Develop and maintain solid knowledge of the relevant therapeutic areas and medical writing techniques. - To undertake any activities involving writing and communication with others, internally and externally, as requested. Professional Experience & Education Requirement - Bachelor degree in Medicine, pharmacology or other life science degrees (or equivalent). - For Specialist, 2+ years of experience in medical writing or clinical science or relevant experience in biopharmaceutical or CRO companies. - For Senior Specialist, 4* years of experience in medical writing, clinical science or relevant experience, plus complex and large scale project management experience in biopharmaceutical or CRO companies. Key Competency Requirement - Understand clinical trial operation process. - Have good knowledge of the regulatory guidance for ICH/GCP. - Excellent Chinese and English written and verbal communication skills; Excellent scientific and technical writing skills in both Chinese and English. - Ability to write fluent and grammatically correct English with solid understanding of medical and scientific terminology and procedures. - Ability to work to tight timelines and changing needs while maintaining accuracy and quality. - Ability to work to a variety of client-driven specifications. 备注: ‘职位月薪’ 仅供参考,具体薪资和福利将根据候选人经验和能力综合评定。

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
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