Specialist/Sr Specialist, Medical Writing


浦东新区-张江镇 | 2年工作经验 | 硕士






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。





• 少于50人

• 制药/生物工程