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 4+ 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.