Job Summary职位概述:

The Medical Writing Specialist oversees delivery/provides input/review of key clinical documents for regulatory submission and other documents not limited to below:

？ Clinical Study Documents

o Clinical study protocols

o Clinical study reports (CSRs)

o Informed consent forms (ICFs)

o Relevant Clinical Validation Plans

？ Documents will cover all Roche Diagnostics in vitro diagnostic products to be launched in China, including Centralised and Point of Care, Molecular Diagnostics, and Diabetes Care.

？ May oversee external vendors to provide writing service for internal MRA projects.

？ Communication/Coordination/Contact point for MRA medical writer’s responsible documents.

医学撰写专员主导注册用重要临床文件的准备、审阅并为文件提供内容输入。文件类型包括但不限于:

？ 临床研究文件

o 临床试验方案

o 临床试验报告

o 知情同意书

o 相关临床评价计划

？ 文件覆盖所有在中国上市的罗氏体外诊断产品种类，包括中心和床旁管理、分子诊断、及糖尿病管理；

？ 可监督外部供应商为MRA内部项目提供写作服务；

？ MRA医学撰写团队负责文件的联系人/协调人/交流者。

Main Tasks & Responsibilities主要工作职责 :

1. For selected and high priority medical documents, oversees and manages the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review and approval processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals).

对于特定的高优先级医学文件，负责监督和管理文件准备和整体递交周期。工作内容包括召开启动会议和主要利益相关团队确定职责范围（内容、质量和时间表），创建文件模板/框架，内部审阅和批准流程（交互质控检查、版本控制、团队审阅和解决修改意见、定稿和批准）。

2. Responsible for the on-time, properly formatted and high quality delivery of clinical study documents and relevant communications in accordance with all relevant company SOPs/procedures, regulatory requirements, and quality control systems/procedures.

负责临床试验文件和有关交流的及时完成、格式规范和高质量交付。工作过程符合公司相关SOP，注册法规要求和质控系统/步骤。

3. Partners with internal and external SMEs and coordinates cross-functional collaborations/meetings to ensure completeness/accuracy in documentation and meet the defined quality, content and timelines.

与内部和外部SME合作，协调跨部门合作/会议以确保文件写作的完整性和准确性，并满足预定的质量、内容和时间。

4. Monitors quality of assigned work and performs consistent, frequent and through quality control checks.

对于分配给自身的工作，监督其质量，进行持续、频繁和完整地质控检查。

5. Serves as the primary contact for assigned work and is accountable for ensuring successful completion, including an obligation to report any concerns or completion risks to the Medical Writing Manager.

对自己的工作负责，确保其成功完成。如果对项目完成有任何风险顾虑，需要向直接经理汇报。

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6. Effectively communicates and builds healthy working relationships with other Medical Writing team members and SMEs with whom he/she will work closely.

有效沟通并与团队内部成员和其他部门SME建立良好的工作关系。

7. Successfully completes all assigned curricula and on-the-job training modules.

确保完成所有分配的课程和工作相关培训模块。

8. Conduct Other projects or tasks assigned by line manager

完成主管指派的其他任务

9. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection

遵循罗氏所有合规要求，包括但不限于罗氏信息安全，罗氏商业中的行为，罗氏竞争法互动对话，罗氏安全健康环境等，合法合理开展业务活动。

Basic Requirements of the Job基本任职资格:

Education& Qualifications教育背景与专业技能:

1. At least Master’s degree or equivalent in medical related, life science, pharmacology, clinical laboratory or biochemistry.

医学、生命科学、药学、临床实验室、或者生物化学硕士及以上学历。

2. Knowledge and understanding of the clinical research process, including ICH GCP, and NMPA guideline for in vitro diagnostic test.

了解临床试验流程，包括ICH GCP和中国国家食品药品监督管理总局对体外诊断检测的指南。

3. Proficiency in reading and written English

熟练掌握英文读写

Experience工作经验:

1. Less than 3 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries.

制药企业和/或者生物科技工业界从事科学研究或医学写作等相关工作经验小于3年。

3. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation

高效的口头及书面沟通技巧; 能够在面对面，小组设置和演示中获得想法

4. Experience working with different document management tools, sharepoint, templates, style guides and expertise with EndNote or equivalent.

熟练使用各种文件管理工具、SharePoint、模板、格式指南，并精通Endnote或类似工具。

Health Conditions 身体状况:

According to the "Quality Management Regulations for Medical Device Management" and the "Regulations on Quality Management of Pharmaceutical Products", health checks should be conducted at least once a year; if you have infectious diseases or other diseases that may contaminate medical devices or drugs shall not be engaged in related work.

根据《医疗器械经营质量管理规范》以及《药品经营质量管理规范》中的有关规定，应当至少每年进行一次健康检查；如患有传染病或者其他可能污染医疗器械或药品的疾病的，不得从事相关工作。

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