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QC of regulatory documents

Keywords / Skills : QC, PSUR, DSUR, CSR, Regulatory documents, Quality Checks

3 - 7 years
Posted: 2019-05-29

Industry
Pharmaceutical
Function
Pharmaceutical/Biotechnology
Role
Other Pharma - QC Regulatory Documents
Posted On
29th May 2019
Job Ref code
GO/JC/10081/2018
Job Description
QC of Regulatory Documents
Experience: 3- 7 yrs 
Job Location: Mumbai

Job Description:
  • QC of Regulatory documents (including but not limited to CSR Narratives CTD Modules ,Investigators Brochure Protocol DSUR PSUR)
  • Ensure that the QC ed documents are in accordance with the company SOPs guidelines and agreed timelines and comply with established standards and performance metrics
  • Provide writing support for patient narratives CSR DSUR as and when required
  • Develop and maintain effective working relationships and facilitate communication among the project team members
  • Identify issues and implement corrective and preventive action.
  • Impart training's and mentor and groom the new incumbents develop therapeutic area and document expertise
  • Disseminate the learning' s and best practices at regular intervals across teams
  • To ensure the completion of authoring QC review of the assigned reports within the specified timelines
  • Complete all training's within timelines scheduled.
  • Provide timely data for preparing metrics and status updates




About Company

Golden Opportunities Pvt. Ltd
About Recruiter
Divya Rani
Recruiter
Golden Opportunities Private Limited
...
Skills I hire for ITES, java, bpo, fresher
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