Opening for Medical Writing/ Scientific Writing at Indegene, Bangalore

Kindly find the job description:
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR, IB, Clinical Overviews & Summaries, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed



Required Skills:
1. Minimum 4 years of experience in pharmaceutical companies in any of the following functionsregulatory-medical writing/developing/publishing medical content
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.

M. Pharm/BDS/ MBBS/ Ph.D with 3 to 4 years of experience in Regulatory Writing

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