【上海企业合规与道德部门经理Manager of Corporate Compliance and Ethics招聘】-百试达上海招聘信息-猎聘

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招聘主管 · 百试达

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职位介绍: 1. Manages day to day compliance and ethics program operations across the Company to ensure adherence to company/client policies and ethical standards (e.g., based on specific OIG Corporate Integrity Agreement requirements applicable to the client), training and education, compliance monitoring mechanisms, and providing ongoing compliance operational support to clients and internal business stakeholders. Provides input for operating strategy, policies and procedures for subordinates and decisions are likely to impact multiple areas and/or client accounts 负责管理公司内日常的合规与道德规范项目运作，以确保遵守公司/客户的相关政策和道德标准（例如，依据适用于客户的特定OIG公司诚信协议的要求），进行培训和教育，建立合规监督机制，并为客户提供持续的合规运营支持以及向内部业务相关方提供此类支持。为下属提供运营策略、政策和程序方面的建议，并且所做出的决策可能会对多个领域和/或客户账户产生影响。制定并生成相关指标和报告信息，以支持首席合规官在公司董事会审计委员会的季度会议上所进行的工作。 2. Develops and generates metrics and reporting information in support of the Chief Compliance Officer for the quarterly meetings of the Company’s Board Audit Committee. 负责制定并生成相关指标及报告信息，以支持首席合规官在公司董事会审计委员会的季度会议上所进行的工作。 3. Manages and implements operations for ensuring accurate and consistent responses to various requests related to the company’s corporate compliance and ethics program from internal stakeholders (e.g., conflict of interest disclosures), clients (e.g., certifications, questionnaires), auditors and governmental bodies (e.g., FINRA). 负责管理和执行相关操作，以确保对来自内部利益相关者（如利益冲突披露）、客户（如认证、调查问卷）以及审计人员和政府机构（如美国金融业管理局）的各种与公司合规与道德计划相关的请求做出准确且一致的回应。 4. Initiates, facilitates, and promotes activities to foster compliance awareness and support the prompt detection and resolution of compliance and ethics issues. 发起、推动并促进相关活动，以增强合规意识，并协助及时发现和解决合规及道德方面的问题。 5. Maintains high level of understanding of applicable compliance laws and regulations and proposes updates and implements operational improvements to the compliance program operations and standard operating procedures, as appropriate in relation to these requirements. 持续保持对适用的合规法律和法规的深刻理解，并根据这些要求的实际情况，提出更新建议并实施合规计划的运营改进措施以及标准操作程序。 6. Support the creation, maintenance and/or implementation of company business and client-specific compliance policies, rules and standard operating procedures to ensure operational compliance by company employees with the following pharmaceutical industry legal, regulatory compliance requirements and ethical standards (as applicable) that govern interactions with health care providers and patients. 支持制定、维护以及/或实施适用于公司业务和客户的具体合规政策、规则及标准操作程序，以确保公司员工在与医疗保健提供者及患者进行互动时遵守以下制药行业相关的法律、监管合规要求以及道德标准（如适用）。 7. Proactively identifies, develops and implements enhancements to improve processes, compliance oversight and to mitigate potential risks to the organization, including implementing updates or enhancements to key compliance program standard operating processes and procedures. Support development of applicable risk management tools and ongoing monitoring to support prompt and effective identification of commercial compliance risks, identification of programmatic gaps and implementation of corrective actions. 主动识别、开发并实施改进措施、以优化流程、加强合规监督，并降低对组织可能造成的风险，包括对关键合规项目的标准操作流程和程序进行更新或改进。支持开发适用的风险管理工具，并持续进行监控，以及时有效地识别商业合规风险、发现程序性漏洞并实施纠正措施。 8. Collaborate with and provide support to internal stakeholders (Corporate Compliance, Human Resources, commercial compliance business management) and clients, as appropriate, when instances of non-compliance with compliance company or client requirements are detected, including in the investigations process to ensure prompt, effective action is taken to determine the nature and extent of the non-compliance, identity root cause and institute effective individual disciplinary action or programmatic changes, as applicable. 当发现违反公司或客户合规要求的情况时（例如在调查过程中），应与内部相关方（公司合规部门、人力资源部门、商业合规业务管理部门）及客户进行合作并提供支持，视情况需要。这包括在调查过程中确保迅速、有效地采取行动，以确定违规行为的性质和程度，查明根本原因，并根据需要采取有效的个人纪律处分措施或制定相应的程序性变更措施。 9. Provides compliance direction and support for the organization. Collaborates with other colleagues and stakeholders including Legal, Human Resources, and local business leadership to ensure corporate compliance policies and operations are properly and consistently implemented across the organization. 为组织提供合规指导和支持。与其他同事及利益相关方(包括法律部门、人力资源部门以及当地业务领导层)合作，以确保公司的合规政策和运营在全组织范围内得到正确且一致的执行。 10. Ensure the effective and strategic use of available databases, systems (e.g., Concur), data, and metrics to conduct effective oversight of applicable commercial compliance operations and determine the effectiveness of existing controls and promote enhancements of these data and systems, as appropriate, for improved commercial compliance strategic and operational support. 确保充分利用现有的数据库、系统（例如Concur系统）、数据和指标、以对相关的商业合规操作进行有效监督，并评估现有控制措施的有效性，同时酌情对这些数据和系统进行改进，以提供更完善的商业合规战略和运营支持。 11. Act as a compliance and ethics role model and ambassador to create awareness and promote compliance with the Company’s Code of Conduct and Business Ethics and other corporate compliance policies (e.g., conflicts of interest, gifts and entertainment, anti-bribery/anti-corruption policy). 作为合规与道德方面的榜样和倡导者，要提高员工对公司的行为准则、商业道德以及其他合规政策（如利益冲突、礼品与娱乐、反贿赂/反腐败政策）的认识，并推动及遵守这些规定。 QUALIFICATION REQUIREMENTS (please indicate if ‘preferred’) 资质要求（请注明“首选”） 1. Bachelor’s Degree and compliance experience in the healthcare (bio/pharma/med device) industry, preferably in both the Commercial and Clinical Development environment. 拥有学士学位，并具备医疗保健（生物/制药/医疗器械）行业的合规管理经验。优先考虑在商业和临床开发领域有相关工作经验者。 2. Excellent written and verbal communication and interpersonal skills required. Ability to interact with all levels of the business. Fluent in English and Chinese. 需要出色的书面和口头沟通能力以及人际交往能力。能够与公司内部各个层级的人员进行交流。英语和汉语都很流利。 3. Ability to drive projects to completion, meeting internal and external timeline driven deliverables with a high degree of accuracy and manage multiple projects simultaneously. 具备推动项目顺利完成的能力，能够严格按照内部和外部设定的时间表交付高质量的成果，并且能够同时管理多个项目。 4. Demonstrated ability to be proactive, exercise independent judgment and demonstrated ability to work effectively on cross-functional teams with all levels of management and external client personnel. 具备主动作为的能力、能够独立做出判断，并且能够与各级管理层以及外部客户人员在跨职能团队中有效合作。 5. Proven ability to collaborate and advice management and clients on compliance and ethics matters and develop practical business solutions to mitigate risk. 具备出色的协作能力，能够就合规与道德问题为管理层和客户提供建议，并制定切实可行的业务解决方案以降低风险。 6. Demonstrated ability exercise critical thinking in applying principles, theories and concepts on a wide range of problems. 具备的能力是在解决各类问题时能够运用原则、理论和概念进行批判性思考。 7. Familiarity with essential “7 elements” components of an effective compliance and ethics program and ability to apply these principles to improve compliance and ethics operations. 具备“7个关键要素“的合规与道德规范体系，以及能够将这些原则应用于提升合规与道德管理工作的能力。 8. Demonstrate current working knowledge of various rules, regulations and industry guidance relevant to healthcare compliance and ethics. 展现对与医疗保健合规及伦理相关的各种规则、条例和行业指导方针的当前掌握程度。 9. Ability to forge strong working relationships with Company colleagues and stakeholders in different disciplines and at all levels of the organization. 能够与公司内部不同部门、不同层级的同事以及相关利益方建立稳固的工作关系。 10. Demonstrate high standards of conduct and ethics as well as appropriate judgment, independence, and discretion. 展现高标准的行为准则和道德规范，同时具备恰当的判断能力、独立性和决断力。 REPORTS TO: Head of Growth and Strategy APAC

其他信息: 语言要求：英语、普通话; 行业要求：制药,生物技术,医疗器械; 所属部门：企业合规与道德部门

公司简介

百试达（上海）医药科技股份有限公司成立于2010 年，是一家国际化创新药物临床开发机构，已连续两次荣获上海市科委高新技术企业称号，服务范围覆盖全国多个中心城市和区域，下属尚睿全资子公司，美国和澳大利亚控股子公司，现有员工已过千人。公司拥有资深专业研究团队，主要研究人员均具有外资制药企业药物研发部和临床研究部工作经验，具有国际化、标准化的业务运作流程和科学严谨的质量保证体系，谙熟国际多中心临床试验和国内各种类型临床试验项目的运作和管理。公司总部位于上海，在北京、南京、广州、成都、武汉设有分支机构，在美国波士顿及澳大利亚悉尼设有联络处和QA 办公室。百试达业务范围包括临床试验的设计、组织、运作和管理，如I-IV 期药物临床试验和医疗器械临床试验项目的策划和筹备、方案撰写、基地筛选、临床监查服务、药物管理、数据管理和生物统计、研究报告撰写。公司还提供药品和医疗器械注册和医学咨询和代理、流行病学观察性研究、医药市场研究和研究者、CRA 和其他临床研究专业人员的培训等。创新药物研发包括化合物和大分子生物制品的筛选，活性药物合成和制剂，化学药物和生物药品的国外专利技术的国内转化以及相应的临床开发。此外，百试达还在临床医学，临床药理学和生物统计领域拥有一大批专家网络资源，并通过高质量的各类人员和项目培训不断扩大这一网络，从而保证各类临床项目的快速和高质量的完成。公司的合作客户包括知名跨国制药公司和医疗器械企业、国内研发型制药企业、医药科研院所以及专业学术团体等。

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