Philips Clinical Development Scientist 

China, Guangdong Province, Bao'an District 

167425731

Clinical Development Scientist

Purpose:

• 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

• Collecting, appraising, and analyzing clinical data pertaining to a (medical) product.
• Writing documentation, such as Clinical Evaluation Reports (CERs), and Post-Market clinical Follow-up reports (PMCF) supporting regulatory submission.
• 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.
• 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.
• 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.
• Providing support for the operation of clinical trials and product approvals in the USA, EU and ROW
• Leading clinical risk assessment throughout – from ideation through Market introduction
• Development of evidence generation & dissemination strategies to support innovation projects
• Delivery of Clinical Development Plans requirements

To succeed in this role, you’ll need a customer-first attitude and the following

• 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.
• Trained and experienced in medical writing; systematic review, and clinical data appraisal: MDR compliant CERs and PMCFs is a plus.
• A demonstrated working knowledge of GCP, ICH guidelines, ISO14155, local and international regulations
• Experience with research methodology (including clinical investigations design and biostatistics)
• Experience with clinical budgeting
• Proven track record of delivering clinical results, on time, within budget, and in compliance with SOPS and regulations
• 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.
• Professional and proficient in reading, writing, and speaking skills in Both English and Chinese are required.

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