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Job Details
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/Master’s 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 4–6 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.
Company Details
Stryker
Kalamazoo, MI, United States
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative... Read more