(Senior) Manager, Medical Compliance (职位编号：25255033)社

面议

市辖区本科及以上1年及以上

发布时间：2023-09-06

职位描述

Principle Roles & Responsibilities / Accountabilities ？ Contribute to Medical Compliance strategy execution with policy implementation and associated ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions. 通过政策执行和相关的伦理和合规性培训，协助医学合规性策略的执行，并支持合规性相关调查以及纠正措施的实施。 ？ Act as a quality consultant to ensure the maintenance of the Affiliate Quality Management System (QMS) by implementation of quality plan and learning/training system in align with Global Quality principles, local regulation requirements and medical compliance strategy. 作为质量顾问，根据全球质量原则、当地法规要求和医学合规策略，通过实施质量计划和学习/培训体系，确保子公司质量管理体系 (QMS) 的运行。 ？ Works in partnership with the local/global department involved in medical activities to maintain/enhance quality standards and to support and improve the efficiency of the China Affiliate in accordance to the Roche SOPs, health authority regulations, healthcare compliance， ICH GCP and GVP. 与参与医学活动的当地/全球部门合作，按照罗氏 SOP、卫生**部门法规、医疗卫生合规，ICH GCP 和 GVP，保持/提高质量标准，支持并提高中国子公司的效率。
Principle Roles & Responsibilities / Accountabilities 主要职责/责任 (Major functions of the position) （职位的首要职能）
1. Medical Compliance Assurance
确保医学合规
1) Contribute to Medical Compliance strategy execution align with Medical Governance requirements, local regulations and Global standards
助力医学合规策略执行与医学管辖要求、当地法规和全球标准保持一致
2) Facilitate developing, implementing, communicating and maintaining medical compliance process with an emphasis on business integrity, operational excellence, and practicality.
协调医学合规流程的建立，实施，沟通和**，强调业务完整性、操作卓越和实用性。
3) Deliver ethics and compliance training, and supporting compliance-related investigations as well as implementation of corrective actions.
推动伦理和合规培训，支持合规相关调查以及纠正措施的实施。
4) Promote ethics & compliance through identification of compliance policy and training needs and development of new and enhanced compliance program activities.
通过确定合规政策和培训需求以及制定新的和强化的合规项目活动来促进伦理和合规。
5) Collaborate with key functional area stakeholders to identify risks and issues that may require training and monitoring, and ensure maintenance of policies, processes and investigative protocols on an ongoing basis.
与关键职能领域的利益相关者合作，确定可能需要培训和监测的风险和问题，并确政策、流程和调查计划的持续**。
6) Acts as a consultant for business activities that involve HCP Compliance risks, and contributes to departmental process and organizational improvements and development, including management Speaker engagements.
担任涉及医疗卫生合规风险的业务活动的顾问，并促进部门流程和组织改进和开发，包括管理讲者聘请活动。
2. QMS maintenance and implement
QMS **和实施
1) Coordinate and contribute to China Quality Management System (QMS) maintenance and implementation.
协调和助力中国质量管理体系 (QMS) 的**和实施。
2) Implement Quality Control for medical activities for responsible Function Departments or areas
对负责职能部门或地区实施的医学活动进行质量控制
？ Plan and conduct the Quality Control to the GCP，GVP and HCP Compliance governed activities, and ensure the CAPA is carried out by responsible Function Departments
计划和实施 GCP、GVP和医疗卫生合规管理活动的质量控制，并确保由负责的职能部门执行纠正和预防措施（ CAPA）
？ Facilitate cross-functions in preparing for audits/inspections and provide inputs into the generation of timely and appropriate CAPA, and ensure the CAPA follow-ups and completeness
促进跨职能部门的审计/检查的准备，并为制定及时和适当的 CAPA 提供支持，确保 CAPA 的跟踪和完整性
？ Reflect the quality issues into trainings and standards development and implementation in responsible Function Departments.
把质量问题反映到相关部门的培训和标准的制定和实施中。
3) Contribute to optimize medical internal process standard
助力优化医学部内部流程标准
？ Coordinate the development and maintenance of Standard Operating Procedures (SOPs) across Medical Division or within SRPL
协调医学部或SRPL相关标准操作规程 (SOP) 的制定和**
？ Coordinate and contribute in the global quality assurance programs such as Inspection Readiness initiative, Quality Risk Management program (QRM), and etc. and drive these programs implementations in China Medical
协调和参与全球质量保证计划，如检查就绪计划，质量风险管理计划等。并在中国医学部推动这些项目的实施
？ Supervise the execution of JD/CV management process in Medical Division
**医学部 JD/CV管理流程的执行
4) If applicable, Be LQR Backup to undertake LQR’s key responsibilities on QMS management in China. Refer to LQR JD for detail information.
如适用，为 LQR 后备，承担 LQR 在中国 QMS 管理方面的主要责任。详细信息参见 LQR JD。
3. Training Compliance and Optimization
培训合规和优化
1) Assess and determine the technical training and development needs of MED&PHC staff (GxP and Medical HCP Compliance focus).
评估和确定医学部人员的技术培训和发展需求（GxP和医疗卫生合规）。
2) Design, develop, deliver and/or organize learning events (e.g. Quality workshop, conference) by leveraging experts/resources from local and global organization or liaising with external trainers.
参与利用当地和全球组织的专家/资源或与外部培训人员联络，设计、开发、提供和/或组织学习活动（例如质量研讨会、会议）。
3) Advance Medical staff awareness of procedures and policies changes to regulation or company requirements.
促进医学部人员对法规或公司要求的程序和政策变更的意识。
4. Partnership with the local/global department
与当地/全球部门的伙伴关系
1) Local Requirements and Operations
当地要求和业务
？ Keep abreast of local regulations pertaining to medical activities that are sponsored or supported by Roche China
与罗氏中国申办或支持的医学活动相关的当地法规保持一致
？ Provide interpretation on local regulations and ensure processes are effectively described in terms that will satisfy local requirements.
提供当地法规的解释，并确保流程的有效描述以满足当地要求。
2) Quality Business Partner
质量业务合作伙伴
？ Provide Medical compliance support by answering questions and providing advice on ICH-GCP/GVP/HCP Compliance, Global SOPs, and local regulations.
通过回答问题并提供有关 ICH-GCP/GVP/医疗卫生合规性、全球 SOP 和当地法规的建议，提供医学合规支持。
？ Provide Medical compliance expert consultancy on trainings of required SOPs/regulatory to applicable Medical staffs.
向适用的医学部人员提供有关所需 SOP/法规的培训和医学合规的专业咨询。
3) Support team leader to actively build up cross-functional compliance communication and collaboration to ensure an effective and seamless interaction with other functions within and outside Medical Division.
支持团队负责人积极建立跨职能合规沟通与协作，以确保与医学部内外的其他职能进行有效和无缝的互动。

Qualification and Experience
Education/Qualifications教育程度/所获资格证书 1) At least with master degree of medicine / pharmacy /Public health. 至少具有医学/药学/公共卫生硕士学位。 2) Relevant working experience: 相关工作经验： ？ At least 5 years experiences including experience in clinical research, pharmacovigilance or HCP compliance with at least 3 years’ medical compliance or quality assurance, such as GxP or Healthcare compliance 至少 5 年经验，包括临床研究、药物警戒或 医疗卫生合规，至少 3 年的医学合规或质量保证经验，例如 GxP或医疗卫生合规。 ？ For senior position, at least 8 years’ experience including experience in clinical research, pharmacovigilance or HCP compliance and 3-5 years’ medical compliance or quality assurance. 高级职位，至少8年经验，包括临床研究或药物警戒经验，3-5 年医学合规或质量保证经验。 ？ Medical Affairs experience is preferred. 有医学事务经验者优先 Job Required Competencies岗位所需胜任力 1) In-depth knowledge of ICH-GCP/GVP/HCP Compliance, SOPs and local regulatory requirements 深入了解 ICH-GCP/GVP/医疗卫生合规、SOP 和当地法规要求 2) An independent and analytical thinking, a strong team player 有**的分析思维，有较强的团队合作精神 3) Good training and presentation skills 良好的培训和演示技巧 4) Good communication and influence skills 良好的沟通和影响力 5) Ability to work independently and cooperation with other teams **工作及与其他团队合作的能力 6) Strong project management skills 较强的项目管理能力 7) Fluent written and verbal English 流利的书面和口语 8) Demonstrated computer literacy, usage of MS Office software, web-based systems and databases. 具备计算机知识，可使用 MS 办公软件，基于 web 的系统和数据库。
Travel Frequency出差频率 <25%

其他要求

招聘人数：1人
职能类别：其他生物工程

公司介绍

上海罗氏制药有限公司成立于1994年，是抗肿瘤、抗**、移植等关键领域的市场领导者。在大型跨国药企中，我们率先在中国建成了包括研究、开发、生产、营销等环节在内的完整的医药价值产业链。罗氏中国正向着成为罗氏全球第三个战略中心的目标迈进，以实际行动践行在中国长期发展的承诺。

我们始终以患者为中心，致力于帮助患者从根本上延长生命和改善生活质量。目前，罗氏在华拥有16个产品，覆盖8个治疗领域。我们与**、医疗机构以及非**组织等社会各界多方携手，共同探索创新的合作模式，通过一系列有影响力和可持续的举措惠及更多的中国患者。

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