Website Merck Group ltd
Post Name: Medical Writer
Your Role:
As an Expert/Senior Expert Medical Writer, you will support medical writing efforts for molecules across therapeutic areas, both globally and at regional/local levels. You will independently prepare clinical and regulatory documents such as protocols, clinical study reports, investigator brochures, and summary documents. Additionally, you will be responsible for supporting submissions for market approval and line extensions with minimal supervision. Your proactive contributions will help develop and implement medical writing best practices and process improvements.
Who You Are:
Minimum Requirements:
Experience: 6 to 10 years in regulatory medical writing.
Education: Graduate or postgraduate degree in relevant fields (BPharm/MPharm, PhD, BDS, BSc/MSc).
Comprehensive knowledge of medical writing theories, principles, and concepts.
Familiarity with clinical and regulatory documents.
Maximum Requirements:
Prepare clinical and regulatory documents independently.
Support submissions for market approval and line extensions.
Contribute to the development of medical writing best practices.
Coordinate with other writers to ensure adherence to business objectives and company standards.
Ensure timely production of documents in compliance with relevant SOPs and regulatory authority requirements.
Participate in meetings related to key medical writing, quality control, and compliance activities.
