Lead (DSUR Writer)

Lead (DSUR Writer)

Golden Opportunities Private Limited
Mumbai
4 - 7 Years
Not Specified

Job Description

Lead (DSUR Writer)
(Mumbai Candidates preferred)


Company: Leading MNC servicing the Leading Communication Fortune 100 companies in Silicon Valley US
Job Location: Mumbai
Working Timings: Candidates should be flexible working in a 24*7 environment
Level: Team Lead


Role:

Authoring and reviewing of safety reports for global regulatory submissions including Development Safety Update Reports (DSUR)
Perform quality reviews for various aggregate reports
Assist in writing subject narratives for adverse drug reactions and serious adverse events
Multi-tasking in order to timely deliver the aggregate reports
Independent QC of regulatory and safety documents
Mentoring and assisting medical writers
Coordinate activities related to various types of report writing across a team of writers
Experience & Skills Required:

Minimum 3 years of Experience as Medical writer with DSUR
Mentoring and assisting medical writers
Independent QC of regulatory and safety documents
Perform quality reviews for various aggregate reports
Good Knowledge about the Databases

Golden Opportunities Pvt. Ltd

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