DSUR Writing / Narrative writing
- Golden Opportunities
- 2 - 8 Years
- Chennai
- 4 years ago
- Email to a friend
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Job Description
Job Description:DSUR Writing / QC:
NARRATIVE WRITING / QC:
- As per process requirement and assigned primary responsibility review DSURs and perform independent QC of safety documents (including but not limited to RMP DSUR other safety periodic documents)
- Ensure that the DSUR safety periodic documents are in accordance with the company SOPs guidelines and agreed timelines and comply with established standards and performance metrics as per customer quality standards
- To understand and interpret data/information and its practical application.
- Develop and maintain effective working relationships and facilitate communication among the project team members
- Attention to detail work under stringent timelines and to switch between different documents
- Perform project management activities for the project/document assigned
- Identify issues and implement corrective and preventive action
- .Disseminate the learning's and best practices at regular intervals across teams.
- Complete all trainings within scheduled timelines
- Provide timely data for preparing metrics and status updates
NARRATIVE WRITING / QC:
- Prepare high quality of Narratives across the Therapeutic Areas.
- Perform Quality check and review of the narratives.
- Prepare narratives according to the SOPs narrative templates and guidance document.
- Initiate project start up meetings with the study teams related to the creation and
- development of the narratives for regulatory submission.
- Collaborate with internal and external study team members for the development review and finalization of compiled narratives and communicating project information in a timely manner
- Revise the compiled narratives as per the comments from the study team members.
Employement Category:
Employement Type: Full timeIndustry: Bio Technology & Life SciencesFunctional Area: PharmaceuticalRole Category: DocumentationRole/Responsibilies: DSUR Writing / Narrative writingContact Details:
Company: Golden OpportunitiesLocation(s): Chennai+ View Contact
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