Senior Medical Writer

Senior 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 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.

Travel Percentage: None

Experience Level

Senior Level