Job Title: Expert Medical Writer
Company: Medtronic
Location: Bangalore, Karnataka, India
Employment Type: Full-time
Experience Required: 6–10 years in regulatory medical writing
Category: Medical / Medical Writing
Role Overview
The Expert Medical Writer independently prepares clinical and regulatory documents for molecules across therapeutic areas, supporting both global and regional submissions. The role ensures compliance with SOPs and regulatory standards while contributing to process improvements and best practices in medical writing.
Key Responsibilities
Document Preparation & Submissions:
Independently prepare clinical and regulatory documents: protocols, clinical study reports, investigator brochures, and summary documents.
Support submissions for market approval and line extensions.
Ensure timely production of documents in compliance with SOPs and regulatory authority requirements.
Process & Collaboration:
Contribute to the development and implementation of medical writing best practices.
Coordinate with other writers to ensure alignment with business objectives and company standards.
Participate in meetings related to medical writing, quality control, and compliance activities.
Compliance & Quality:
Maintain familiarity with clinical and regulatory documents.
Ensure adherence to relevant guidelines, SOPs, and authority requirements.
Required Qualifications & Skills
Graduate or postgraduate degree in relevant fields (BPharm/MPharm, PhD, BDS, BSc/MSc).
6–10 years of experience in regulatory medical writing.
Comprehensive knowledge of medical writing theories, principles, and concepts.
Familiarity with clinical and regulatory documentation requirements.
Strong written and verbal communication skills.
Ability to work independently with minimal supervision.
Company Overview
Medtronic is a global healthcare technology company focused on improving patient outcomes through medicines, devices, and digital innovations. Employees benefit from a diverse, inclusive, and collaborative culture, with opportunities for personal development and career advancement across the globe.
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