Senior Clinical Development Scientist, Ultrasound &EI

• 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.

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

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

• 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