Job Summary职位概述:

The Medical Writer 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.

The primary focus of the Medical Writer will be on the generation of medical regulatory/scientific content and on the high quality, properly formatted and timely delivery of selected high priority Clinical Study Documents and relevant MRA medical writer’s communications. Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs to provide content), comments resolution, attention to detail, quality control, accountability, and strict adherence to company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices.

The Medical Writer will be working closely with relevant stakeholders/SMEs that share the responsibilities for generating, changing and/or updating medical regulatory content. S/He also serve as the primary contact point for most of the documents.

（资深）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。

（资深）医学撰写专员的主要工作重点是为特定的高优先级临床试验文件提供医学注册/科学内容，并为这些文件的高质量、格式规范和及时交付负责；同时也负责MRA医学撰写有关的交流工作。成功完成文件需要灵活的时间表管理，协调跨部门会议，与各职能部门专家（提供内容的专家）高效及时沟通，解决修改意见，注重细节和质量，严格遵守公司SOP、政策、指令、集团子公司标准、赫尔辛基宣言、业界标准、有关质量管理规范、以及中国监管部门/国际准则/***操作。医学撰写团队将同各利益相关方/SME紧密合作，分担医学注册文件的准备、修改和更新。她/他也将承担大多数文件的主要联络人工作。

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).

JD (Sr.) Medical Writer_Version 1.0_Date 10Jan2019 Page 2 of 4

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。

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。

职能类别：药品注册

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