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Wednesday, 12 February 2014

Senior Associate - Regulatory Writing

Senior Associate - Regulatory Writing 
Indegene Lifesystems Private Limited - Bangalore, Karnataka


Operational Responsibilities
 
1. Responsible for Regulatory and safety services at Indegene
2. Review and assessment of quality and integrity of data, documents and timelines of delivery.
3. Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards.
4. Review and update SOPs for completeness and updates as needed.
5. Review and write proposals and project status reports

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