Senior Medical Writer - Clinical and Regulatory Documentation

Staff Medical Writer

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/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.

Travel Percentage: None

Experience Level

Senior Level