Job Title

Job Description

Job Responsibilities:
• Analyzes clinical trial protocols and studies, ensuring adherence to regulatory requirements and alignment with strategic objectives, providing recommendations for protocol optimization and enhancement.
• Crafts comprehensive and compliant Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions, employing advanced-level proficiency in standard software tools and systems, adhering to internal procedures, templates, and external standards, regulations, and guidance.
• Troubleshoots complex issues related to clinical data collection, analysis, and reporting, leveraging analytical skills to ensure data integrity, accuracy, and consistency across studies, working under some supervision.
• Assesses and critically analyzes clinical study data within the clinical study report, synthesizing findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications, contributing to the advancement of scientific knowledge.
• Develops Clinical Development and Market Access strategies, referencing applicable business processes, and contributes to the development of clinical protocols in accordance with relevant standards and regulations, ensuring strategic alignment and regulatory compliance.
• Performs comprehensive literature searches and in-depth reviews to support evidence-generation processes for both New Product Introduction (NPI) and Life Cycle Management (LCM) initiatives, providing critical insights and evidence-based support for decision-making.
• Supports relationships with Key Opinion Leaders (KOLs) and Investigators, facilitating the execution of clinical studies and ensuring robust data generation, contributing to the credibility and success of clinical development programs.
• Interacts closely with colleagues to determine and implement optimal approaches for evidence generation and clinical study design, promoting a culture of innovation and excellence within the clinical development team.
• Presents findings from literature reviews and data analyses to internal stakeholders, contributing to informed decision-making processes and strategic discussions.
• Disseminates evidence derived from clinical studies, effectively communicating the impact and significance of findings to internal teams and external stakeholders, contributing to the broader scientific community and market understanding.

Minimum required Education:
Master's Degree in Clinical Medicine.

Minimum required Experience:

MD preferred, with Clinical experience in equipment or device / R&D experiences 3 years.

Preferred Skills:
• Regulatory Compliance
• Data Analysis & Interpretation
• Continuous Improvement
• Business Acumen
• Project Management
• Strategic Planning
• KPI Management
• Document Auditing
• Medical Terminology
• Medical Writing
• Regulatory Requirements
• Clinical Evaluation Methodologies
• Clinical Evidence Generation Strategy
• Report Writing