Work Flexibility: Hybrid
What will you do:
- Conduct systematic literature searches using scientific databases and search tools.
- Critically analyze and summarize clinical data from published literature and other scientific sources.
- Develop literature search protocols screening strategies and documentation.
- Maintain strong working knowledge of global medical device approval pathways with emphasis on EU MDR and European regulatory frameworks.
- Demonstrate thorough understanding of Good Clinical Practice (GCP) applicable standards and industry practices.
- Maintain professional expertise by regularly reviewing clinical literature and contributing in cross-functional project meetings.
- Understanding of Clinical Study related documents.
What you need:
Basic Qualifications:
- Postgraduate degree/Masters in allied paramedical fields (Pharmacy Biotechnology Biomedical Engineering etc.)
- Minimum 5 years of experience in delivering high-quality scientific and clinical writing with attention to detail.
- Expertise in scientific literature databases such as:PubMed Embase Google Scholar ProQuest Cochrane etc.
- Understanding of medical device technologies classifications and clinical applications.
- Strong understanding of medical device regulations (knowledge in EU MDR ISO 14971) clinical evaluation risk-benefit analysis.
- Ability to work in collaboration with cross-functional teams including:
R&D Regulatory Affairs Clinical Affairs Clinical Safety Biostatistics Data Management Product Management and external stakeholders. - Well verse with MS Office / MS Word
- Excellent communication and presentation skills
Preferred Qualifications:
- PhD in allied health sciences with 46 years of experience
- Experience in using tools such as: Distiller Readcube Endnote Power BI etc.
- Good analytical and problem-solving skills
- Ability to work with minimal supervision managing multiple deliverables and ensuring compliance with applicable global regulatory and quality standards
- Strong accountability and ownership to ensure deliverables meet timelines and compliance requirements.
Travel Percentage: None
Required Experience:
Staff IC
Work Flexibility: HybridWhat will you do:Conduct systematic literature searches using scientific databases and search tools.Critically analyze and summarize clinical data from published literature and other scientific sources.Develop literature search protocols screening strategies and documentation...
Work Flexibility: Hybrid
What will you do:
- Conduct systematic literature searches using scientific databases and search tools.
- Critically analyze and summarize clinical data from published literature and other scientific sources.
- Develop literature search protocols screening strategies and documentation.
- Maintain strong working knowledge of global medical device approval pathways with emphasis on EU MDR and European regulatory frameworks.
- Demonstrate thorough understanding of Good Clinical Practice (GCP) applicable standards and industry practices.
- Maintain professional expertise by regularly reviewing clinical literature and contributing in cross-functional project meetings.
- Understanding of Clinical Study related documents.
What you need:
Basic Qualifications:
- Postgraduate degree/Masters in allied paramedical fields (Pharmacy Biotechnology Biomedical Engineering etc.)
- Minimum 5 years of experience in delivering high-quality scientific and clinical writing with attention to detail.
- Expertise in scientific literature databases such as:PubMed Embase Google Scholar ProQuest Cochrane etc.
- Understanding of medical device technologies classifications and clinical applications.
- Strong understanding of medical device regulations (knowledge in EU MDR ISO 14971) clinical evaluation risk-benefit analysis.
- Ability to work in collaboration with cross-functional teams including:
R&D Regulatory Affairs Clinical Affairs Clinical Safety Biostatistics Data Management Product Management and external stakeholders. - Well verse with MS Office / MS Word
- Excellent communication and presentation skills
Preferred Qualifications:
- PhD in allied health sciences with 46 years of experience
- Experience in using tools such as: Distiller Readcube Endnote Power BI etc.
- Good analytical and problem-solving skills
- Ability to work with minimal supervision managing multiple deliverables and ensuring compliance with applicable global regulatory and quality standards
- Strong accountability and ownership to ensure deliverables meet timelines and compliance requirements.
Travel Percentage: None
Required Experience:
Staff IC
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