West is seeking a Lead Medical Writer for their Applied Research & Medical Affairs team in Bengaluru, KA, IN. The role demands strong scientific writing skills and experience in the medical device field, focusing on creating clinical evaluation documentation while ensuring regulatory compliance
Job Summary
The Senior/Lead Medical Writer role with the Applied Research & Medical Affairs team is focused on scientifically communicating medical information, requiring strong scientific knowledge and writing skills.
The position involves authoring and overseeing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Post-Market Surveillance Reports (PMSRs), PSURs, and PMCF documents.
As a subject matter expert and primary team contact, the role includes guiding content development, managing projects, and quality assurance, ensuring timely delivery of high-quality documents that align with clinical and regulatory standards.
Matching Summary
Match Score: 85
West is seeking a Lead Medical Writer for their Applied Research & Medical Affairs team in Bengaluru, KA, IN. The role demands strong scientific writing skills and experience in the medical device field, focusing on creating clinical evaluation documentation while ensuring regulatory compliance.
Skills & Requirements
Must-have
authoring Clinical Evaluation Reports
literature evaluation and data synthesis
regulatory compliance
project management and quality assurance
mentoring junior writers
Nice-to-have
lifelong learning and growth opportunities
inclusive community
sustainability efforts
Key Requirements
5-8 years relevant experience
8 years in medical device clinical affairs
Degree or postgraduate qualification in Life Sciences or pharmacy or Biomedical Engineering