苏州招聘

Purpose:
61 Accountable for clinical evidence strategy development, delivery & dissemination throughout the entire product creation and life cycle to deliver evidence of value.

You are responsible for
61 Collecting, appraising, and analyzing clinical data pertaining to a (medical) product.
61 Writing documentation, such as Clinical Evaluation Reports (CERs), and Post-Market clinical Follow-up reports (PMCF) supporting regulatory submission.
61 Collaborating with internal (project owners, regulatory, study managers, statisticians, business leaders, post-market surveillance, risk management, Marketing, legal, etc.) and external (clinical consultants, subject matter experts, regulatory agencies, etc.) stakeholders to ensure comprehensive analysis of clinical evidence.
61 Ensuring appropriate interpretation and dissemination of all evidence generated, including writing Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), Post-Market clinical Follow-up (PMCF) Reports, and supporting the timely publication of study results.
61 Creating procedures and workflows related to the Clinical Development department. Review, assess, and revise document preparation procedures and SOPs regarding their efficiency, workflow, and implementation.
61 Providing support for the operation of clinical trials and product approvals in the USA, EU and ROW
61 Leading clinical risk assessment throughout – from ideation through Market introduction
61 Development of evidence generation & dissemination strategies to support innovation projects
61 Delivery of Clinical Development Plans requirements


To succeed in this role, you’ll need a customer-first attitude and the following
61 Preferably Masters or PhD degree in biomedical Science or Health-related field or M.D. with 3-5 years of experience in the medical device or Pharma industry or consumer electronics.
61 Trained and experienced in medical writing; systematic review, and clinical data appraisal: MDR compliant CERs and PMCFs is a plus.
61 A demonstrated working knowledge of GCP, ICH guidelines, ISO14155, local and international regulations
61 Experience with research methodology (including clinical investigations design and biostatistics)
61 Experience with clinical budgeting
61 Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPS and regulations
61 Ability to collaborate effectively with various teams – clinical operations, engineering, cross-functional team members, as well as external partners
Preferably CRA or Clinical Study Management experience in a pharmaceutical, medical device or biologic clinical studies research setting.
61 Professional and proficient in reading, writing, and speaking skills in Both English and Chinese are required.

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        飞利浦公司总部位于荷兰，2021年销售额达172亿欧元，在全球拥有大约78,000名员工，销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。

        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

创美好，做真我，迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。