Senior Clinical Development Scientist - Ultrasound &EI

Job Title

Senior Clinical Development Scientist, Ultrasound &EI

Job Description

In this role, you have the opportunity to

Be a member of the medical and clinical affairs team in Greater China.

Medical and Clinical affairs team is an integral part of global Chief Medical Office. The Clinical Development Scientist is responsible for executing evidence-generation processes, clinical development and market access strategies for New Product Introduction (NPI) projects and post-market activities. The role is responsible for analyzing clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributes to the study designs. The role drafts comprehensive Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and regulatory submissions, ensuring accuracy and compliance with regulatory requirements. The role maintains data integrity and accuracy throughout studies and performs rigorous literature searches and critical reviews to support evidence-generation processes, providing insights for strategic decision-making.

You are responsible for

• Assesses clinical trial protocols and studies, ensuring alignment with regulatory standards and business objectives, and contributing to the development and refinement of study designs as needed, working under direct supervision.
• Executes clinical development and market access strategies for assigned New Product Introduction (NPI) projects and post-market activities, integrating inputs from stakeholders such as Marketing/BU Claims, regional/market needs, Health Economics, Market Access, and Post Market Surveillance (PMS).
• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.
• Troubleshoots issues related to clinical data collection, analysis, and reporting, applying analytical skills to ensure data integrity and accuracy, and proactively addressing challenges to maintain study outcomes.
• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.
• Acquires and applies deep domain knowledge in technology and therapeutic areas, leveraging expertise to enhance clinical development activities, staying abreast of industry trends and advancements.
• Produces high-quality documentation through the proficient use of standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance to ensure compliance and clarity in documentation practices.
• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing meticulous attention to detail and adherence to regulatory standards.

You are part of

Medical and Clinical Affairs team in Greater China.You will be based in Shanghai.

To succeed in this role, you should have the following skills and experience

Educational background:

Master or PhD in medical science or clinical medicine or Biomedical or equivalent

Work experience:

• Minimum for 2 years of relevant industry experience (e.g. Med. Device field).
• Minimum 2 years of experience in clinical evaluation or clinical research.

Abilities and skills:

• Excellent in English speaking and writing
• Regulatory Requirements & Regulation Compliance
• Data Analysis & Interpretation
• Scientific Literature Reviews
• New Product Introduction (NPI)
• Product Lifecycle Management (PLM)
• Research & Analysis
• Clinical Evidence Communication
• Communications Development
• Clinical Study Management
• Data Analysis & Interpretation
• Clinical Evaluation Methodologies
• Clinical Evidence Generation Strategy
• Medical Writing

In return, we offer you

A path towards your most rewarding career. Succeeding in this role will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer ambitious health benefits, a flexible work schedule and access to local well-being focused activities. You will also enjoy a professional but fun workplace, a healthy work-life balance environment and an energetic, authentic, inventive, encouraging and dynamic team atmosphere.